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CTC Index Terms - Cancer Therapy Evaluation Program (CTEP)

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CTC Index Terms ADH AGC ALT ALT (SGPT) ANC ARDS AST AST (SGOT) AV block AV heart block AVN Anorexia BM BMT BP Index Term SIADH (syndrome of inappropriate antidiuretic hormone) Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C) Neutrophils/granulocytes (ANC/AGC) SGPT (ALT) (serum glutamic pyruvic transaminase) SGPT (ALT) (serum glutamic pyruvic transaminase) Febrile neutropenia (fever of unknown origin without clinically or microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5 degrees C) Neutrophils/granulocytes (ANC/AGC) Adult respiratory distress syndrome (ARDS) SGOT (AST) (serum glutamic oxaloacetic transaminase) SGOT (AST) (serum glutamic oxaloacetic transaminase) Conduction abnormality/Atrioventricular heart block Conduction abnormality/Atrioventricular heart block Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity, cutaneous striae) Anorexia Hypothyroidism Mood alteration-depression Pancreatitis SIADH (syndrome of inappropriate antidiuretic hormone) Weight loss Constipation Bilirubin associated with graft versus host disease (GVHD) for BMT studies, if specified in the protocol. Diarrhea associated with graft versus host disease (GVHD) for BMT studies, if specified in the protocol. Diarrhea for pediatric BMT studies, if specified in the protocol. Diarrhea patients with a colostomy Diarrhea patients without colostomy Leukocytes (total WBC) Neutrophils/granulocytes (ANC/AGC) Platelets Rash/desquamation Stomatitis/pharyngitis (oral/pharyngeal mucositis) Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTP or hemolytic uremic syndrome/HUS) Transfusion: Platelets Transfusion: pRBCs Weight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified in the protocol. CNS hemorrhage/bleeding Hemorrhage/bleeding associated with surgery Hemorrhage/bleeding with grade 3 or 4 thrombocytopenia Adverse Event 11324 900162 5765 8379 8379 900162 5765 8619 8377 8377 9240 9240 21193 127 1081 17644 7234 11324 23368 8174 900160 900148 900150 900146 21197 10407 5765 20042 18204 2395 21610 23746 23748 900134 23826 21518 900156 IMT Code
Transcript

CTC Index Terms

ADHAGC

ALTALT (SGPT)ANC

ARDSASTAST (SGOT)AV blockAV heart blockAVN

Anorexia

BMBMT

BP

Index Term

SIADH (syndrome of inappropriate antidiuretic hormone)Febrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Neutrophils/granulocytes (ANC/AGC)SGPT (ALT) (serum glutamic pyruvic transaminase)SGPT (ALT) (serum glutamic pyruvic transaminase)Febrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Neutrophils/granulocytes (ANC/AGC)Adult respiratory distress syndrome (ARDS)SGOT (AST) (serum glutamic oxaloacetic transaminase)SGOT (AST) (serum glutamic oxaloacetic transaminase)Conduction abnormality/Atrioventricular heart blockConduction abnormality/Atrioventricular heart blockCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)AnorexiaHypothyroidismMood alteration-depressionPancreatitisSIADH (syndrome of inappropriate antidiuretic hormone)Weight lossConstipationBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyLeukocytes (total WBC)Neutrophils/granulocytes (ANC/AGC)PlateletsRash/desquamationStomatitis/pharyngitis (oral/pharyngeal mucositis)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: PlateletsTransfusion: pRBCsWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.CNS hemorrhage/bleedingHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopenia

Adverse Event

11324900162

576583798379900162

57658619837783779240924021193

127108117644723411324233688174900160

900148

900150900146211971040757652004218204239521610

2374623748900134

2382621518900156

IMT Code

CTC Index Terms

BP

Babinski

CD4CHF

CNSCNS bleeding

CNS hemorrhage

CPAPCPKCSF CVA

Chvostek's signCoomb'sCrohn's disease Cushing's

Cushingoid

D-dimerDATDIC

DLCO

Index Term

Hemorrhage/bleeding without grade 3 or 4 thrombocytopeniaHypertensionHypotensionPyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)CD4 countCardiac left ventricular functionConduction abnormality/Atrioventricular heart blockDyspnea (shortness of breath)MyocarditisNodal/junctional arrhythmia/dysrhythmiaProlonged QTc interval (QTc > 0.48 seconds)Sinus bradycardiaSinus tachycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)CNS hemorrhage/bleedingCNS hemorrhage/bleedingHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaCNS hemorrhage/bleedingHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)HypoxiaMyositis (inflammation/damage of muscle)Arachnoiditis/meningismus/radiculitisCNS cerebrovascular ischemiaCNS hemorrhage/bleedingSyncope (fainting)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)HypocalcemiaHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)ColitisCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Weight gainDIC (disseminated intravascular coagulation)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)DIC (disseminated intravascular coagulation)Hemorrhage/bleeding associated with surgeryCarbon monoxide diffusion capacity (DL(co))

Adverse Event

1779718349513911033

212731215924070518219041907862986297179439043238262382690015617797238269001561779721610

176391785410341957223826643221610

545110451814221193

21193

209381040010451104002151825718

IMT Code

CTC Index Terms

DM

DVTECG

ECG EEGEKG

Fanconi'sFanconi's syndromeGI bleeding

GI painGTTGVHD

Glasgow comascaleHLA

HTNHUS

Hohman's sign

Index Term

HyperglycemiaHypoglycemiaThrombosis/embolismConduction abnormality/Atrioventricular heart blockHypokalemiaMyocarditisNodal/junctional arrhythmia/dysrhythmiaProlonged QTc interval (QTc > 0.48 seconds)Sinus bradycardiaSinus tachycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Pericardial effusion/pericarditisLeukoencephalopathy associated with radiological findingsConduction abnormality/Atrioventricular heart blockHypokalemiaMyocarditisNodal/junctional arrhythmia/dysrhythmiaPericardial effusion/pericarditisProlonged QTc interval (QTc > 0.48 seconds)Sinus bradycardiaSinus tachycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)HypophosphatemiaCNS hemorrhage/bleedingColitisHematemesisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaMelena/GI bleedingWeight lossAbdominal pain or crampingGGT (Gamma-Glutamyl transpeptidase)Bilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Depressed level of consciousness

PlateletsTransfusion: PlateletsHypertensionThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Thrombosis/embolism

Adverse Event

20900107517798924054551821904190786298629717943904392121034792405455182190419212907862986297179439043233551162323826814296590015617797129923368175808375900160

17406

20042237461834921610

17798

IMT Code

CTC Index Terms

ICPIVIV fluids

JacksonianKernig's signLNLOC

MI

MUGAMobitz type IMobitz type IIPE

PTPTTPVCsQTQTcRBC

RBC destruction

RTA

Index Term

Arachnoiditis/meningismus/radiculitisCatheter-related infectionAnorexiaDehydrationDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)HypermagnesemiaNauseaStomatitis/pharyngitis (oral/pharyngeal mucositis)Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)VomitingSeizure(s)Arachnoiditis/meningismus/radiculitisLymphaticsArachnoiditis/meningismus/radiculitisCNS hemorrhage/bleedingDepressed level of consciousnessSeizure(s)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)CPK (creatine phosphokinase)Cardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cardiac-ischemia/infarctionHypotensionOperative injury of vein/arteryCardiac left ventricular functionConduction abnormality/Atrioventricular heart blockConduction abnormality/Atrioventricular heart blockDyspnea (shortness of breath)Thrombosis/embolismProthrombin time (PT)Partial thromboplastin time (PTT)Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Prolonged QTc interval (QTc > 0.48 seconds)Prolonged QTc interval (QTc > 0.48 seconds)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Hypophosphatemia

Adverse Event

10341229321274966142979935101759

1162413772395233552116231501034122958103412382617406315021610

118692616826167966551399001261215924092407051779825273175559043907890781045121610

21610

11623

IMT Code

CTC Index Terms

RTASGOTSGPTSIADH

SOB

ST-wave changesSVTStevens-JohnsonsyndromeT-wave changes

T-wave flatteningT2 hyperintensitiesTEN

TIA

TMJ

TPNTSHTTP

TURPTVTodd's paralysisVOD

WBC

Wenckebachabdominal pain

Index Term

Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)SGOT (AST) (serum glutamic oxaloacetic transaminase)SGPT (ALT) (serum glutamic pyruvic transaminase)HyponatremiaSIADH (syndrome of inappropriate antidiuretic hormone)Adult respiratory distress syndrome (ARDS)Dyspnea (shortness of breath)PneumothoraxPulmonary fibrosisCardiac-ischemia/infarctionSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Cardiac-ischemia/infarctionHyperkalemiaCardiac-ischemia/infarctionLeukoencephalopathy associated with radiological findingsErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)CNS cerebrovascular ischemiaSyncope (fainting)Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies)AnorexiaHypothyroidismThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Urinary retention FEV (1)Seizure(s)Portal vein flowWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.Arachnoiditis/meningismus/radiculitisFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Leukocytes (total WBC)LymphopeniaNeutrophils/granulocytes (ANC/AGC)Conduction abnormality/Atrioventricular heart blockAbdominal pain or crampingAscites (non-malignant)ColitisDuodenal ulcer (requires radiographic or endoscopic documentation)Dyspepsia/heartburn

Adverse Event

23355837783795453113248619705211498571966517943759

96655454966510347759

9572643218654

127108121610

25851247231506061900134

10341900162

10407107515765924017580181814269117612

IMT Code

CTC Index Terms

abdominal pain

abscess

achalasia

ache

aching

acidosis

acquired hemolyticanemiaacrocyanosisactinic keratosisactivityacute capillary leakacute myocardialinfarctionacute tubularnecrosisacute vascular leakadhesions

adrenal dysfunction

Index Term

Gastric ulcer (requires radiographic or endoscopic documentation)GastritisHepatic painLiver dysfunction/failure (clinical)PancreatitisPelvic painPortal vein flowTyphlitis (inflammation of cecum)ColitisFistula-esophagealFistula-intestinalFistula-pharyngealFistula-rectal/analInfection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCPancreatitisProctitisWound-infectiousDysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationAbdominal pain or crampingEarache (otalgia)Hepatic painMyalgia (muscle pain)Abdominal pain or crampingArthralgia (joint pain)Bone painAcidosis (metabolic or respiratory)Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Autoimmune reaction

DIC (disseminated intravascular coagulation)Keratitis (corneal inflammation/corneal ulceration)Neuropathy - motorAcute vascular leak syndromeCardiac-ischemia/infarction

DIC (disseminated intravascular coagulation)

Acute vascular leak syndromeColitisFistula-intestinalFistula-rectal/analMasculinization of female

Adverse Event

9239258365833772341345860612374981422044322145900142105900164

900166723420341255507993510117580708836513551758046081607819281233554634

10400118218173186409665

10400

1864081422214510511358

IMT Code

CTC Index Terms

adrenal tumoradrenal virilismadult respiratorydistress syndromeagitation

aguesiaalbumin

alcohol ingestionalkalinealkalinephosphatasealkalosisallergicallergic reaction

allergic rhinitisallergy

alopecia

amenorrheaaminoaciduriaamnesiaamphotericinamputation

amylase

anal

anal incontinence

Index Term

HypokalemiaMasculinization of femaleAdult respiratory distress syndrome (ARDS)

Irritability (children <3 years of age)Mood alteration-anxiety, agitationTaste disturbance (dysgeusia)Acute vascular leak syndromeHypoalbuminemiaGGT (Gamma-Glutamyl transpeptidase)Alkalosis (metabolic or respiratory)Alkaline phosphatase

Alkalosis (metabolic or respiratory)Allergic reaction/hypersensitivity (including drug fever)Allergic reaction/hypersensitivity (including drug fever)Autoimmune reactionFever (in the absence of neutropenia, where neutropenia is defined asAGC<1.0 x 10e9/L)Radiation dermatitisRash/desquamationVasculitisAllergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)Allergic reaction/hypersensitivity (including drug fever)Fever (in the absence of neutropenia, where neutropenia is defined asAGC<1.0 x 10e9/L)Rash/desquamationVasculitisAlopeciaHypothyroidismHypothyroidismUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Memory lossHypokalemiaPeripheral arterial ischemiaVasculitisAmylasePancreatitisFistula-rectal/analProctitisDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyNeuropathy-sensory

Adverse Event

5455113588619

180741812217407186401957083751928317337

19283193491934946346180

2204718204940119427193496180

18204940177108110812335510298545517938940121332723410520341900148

9001509001462119718172

IMT Code

CTC Index Terms

anaphylaxisanasarcaanastomosisandrogensanemia

angiitisangina

angioedemaangioneuroticedemaanosmiaantacidsanti-androgensanti-estrogensantibiotics

antibody

anticoagulants

antidiuretichormoneantifungals

Index Term

Allergic reaction/hypersensitivity (including drug fever)EdemaOperative injury to bladder and/or ureterTumor flareAutoimmune reactionCNS hemorrhage/bleedingEpistaxisHematemesisHematuria (in the absence of vaginal bleeding)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Hemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaMelena/GI bleedingPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Rectal bleeding/hematocheziaTransfusion: pRBCsVaginal bleedingVasculitisCardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cardiac-ischemia/infarctionHypotensionAllergic reaction/hypersensitivity (including drug fever)Serum sickness

Sense of smellHypermagnesemiaTumor flareTumor flareCatheter-related infectionFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCInfection without neutropeniaHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)PlateletsPhlebitis (superficial)Thrombosis/embolismSIADH (syndrome of inappropriate antidiuretic hormone)

Febrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)

Adverse Event

193491836013962237514634238267559659701045121518900156129993462120237481751194012616826167966551391934915347

1022211624237512375122932900162

900164

900166178151045120042238151779811324

900162

IMT Code

CTC Index Terms

antifungals

antigen-antibodyreactionantiglobulinantitussiveanuriaanusanxiety

aphagia

aphasia

aplasiaapneaapneicappetite

apprehensivearachnoiditisarrhythmia

arterial

arterial diseasearterial ischemiaarteryarthralgia

arthritis

Index Term

Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCInfection without neutropeniaSerum sickness

Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)CoughRenal failureFistula-rectal/analAdult respiratory distress syndrome (ARDS)Mood alteration-anxiety, agitationDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationCNS cerebrovascular ischemiaSpeech impairment (e.g., dysphasia or aphasia)Bone marrow cellularityApneaApneaAnorexiaPancreatitisMood alteration-anxiety, agitationArachnoiditis/meningismus/radiculitisConduction abnormality/Atrioventricular heart blockHyperkalemiaHypermagnesemiaHypokalemiaNodal/junctional arrhythmia/dysrhythmiaProlonged QTc interval (QTc > 0.48 seconds)Sinus bradycardiaSinus tachycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Syncope (fainting)Vasovagal episodeVentricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Hemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaPeripheral arterial ischemiaVisceral arterial ischemia (non-myocardial)Operative injury of vein/arteryArthralgia (joint pain)Serum sicknessArthralgia (joint pain)Autoimmune reaction

Adverse Event

900164

9001661781515347

10451543125241058619181221429799351019572133531064021306213061277234181221034192405454116245455904190786298629717943643218500904390015617797179382616990012646081534746084634

IMT Code

CTC Index Terms

arthrodyniaartificial tearsascites

aseptic necrosis

aspirationasterixisastheniaasthma

ataxia

atoniaatrial fibrillationatrial flutterattention deficitattention seekingaudiometryauditory

auraautoimmune

avascular necrosisawarenessbacteriabad dreamsbalance

baldnessbarking coughbasebedridden

Index Term

Arthralgia (joint pain)Dry eyeAscites (non-malignant)Liver dysfunction/failure (clinical)Weight gainWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Stomatitis/pharyngitis (oral/pharyngeal mucositis)Liver dysfunction/failure (clinical)Fatigue (lethargy, malaise, asthenia)Dyspnea (shortness of breath)Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Ataxia (incoordination)HypoglycemiaHypothyroidismColitisSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)ConfusionIrritability (children <3 years of age)Inner ear/hearingEarache (otalgia)External Auditory CanalHeadacheAutoimmune reactionPlateletsOsteonecrosis (avascular necrosis)Cognitive disturbance/learning problems (for pediatrics)Dysuria (painful urination)HallucinationsAtaxia (incoordination)Neuropathy - cranialVertigoAlopeciaCoughBicarbonateArachnoiditis/meningismus/radiculitisAtaxia (incoordination)Extrapyramidal/involuntary movement/restlessnessFatigue (lethargy, malaise, asthenia)Muscle weakness (not due to neuropathy)Myositis (inflammation/damage of muscle)Neuropathy - motor

Adverse Event

460823759181833720938900134

21193

2395833714237051024117846107510818142179431794318115180741920470818549974634200421829924832706537617846228822090777543203461034117846110711423174011785418173

IMT Code

CTC Index Terms

bedridden

behavior

bicarbonate

bicarbonate lossbigeminybilirubin

black tarry stoolsbladder

bladder

blebsbleeding

Index Term

Pyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)VertigoConfusionPersonality/behavioralBicarbonateUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Acidosis (metabolic or respiratory)Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)BilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Melena/GI bleedingBladder spasmsOperative injury to bladder and/or ureterUrinary retention Hematuria (in the absence of vaginal bleeding)IncontinenceRash/desquamationAutoimmune reactionBruising (in absence of grade 3 or 4 thrombocytopenia)CNS hemorrhage/bleedingColitisDIC (disseminated intravascular coagulation)Diarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyDuodenal ulcer (requires radiographic or endoscopic documentation)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationEpistaxisFibrinogenGastric ulcer (requires radiographic or endoscopic documentation)GastritisHematemesisHematuria (in the absence of vaginal bleeding)HemoglobinHemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaMelena/GI bleedingMucositis due to radiation

Adverse Event

11033

209071811518124203462335519281904321521900160

12992166813962258597025841820446341991523826814210400900148

900150900146211976917993510175521203923925965970106179762151890015617797129918489

IMT Code

CTC Index Terms

bleeding

bleeding into skin

bleeding withsurgery

blindnessblisters

bloatingblood

blood

blood culture

Index Term

Partial thromboplastin time (PTT)Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)PlateletsProctitisRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Rectal bleeding/hematocheziaStomatitis/pharyngitis (oral/pharyngeal mucositis)Thrombosis/embolismThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: PlateletsTransfusion: pRBCsTyphlitis (inflammation of cecum)Vaginal bleedingVomitingHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Hemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaGlaucomaPhotosensitivityRash/desquamationDyspepsia/heartburnCNS hemorrhage/bleedingDIC (disseminated intravascular coagulation)EpistaxisFibrinogenHematemesisHemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Rectal bleeding/hematocheziaVaginal bleedingDysuria (painful urination)Hematuria (in the absence of vaginal bleeding)Hemorrhage/bleeding with grade 3 or 4 thrombocytopeniaRash/desquamationCatheter-related infectionInfection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)

Adverse Event

17555934620042203412204718490

212023951779821610

2374623748237491751121162900156177979346215189001561779794160001820417612238261040075521203965976215181779793462120175117069709001561820422932900164

IMT Code

CTC Index Terms

blood culture

blood pressure

blood sugar

blood vesselsbloody stools

blurred vision

blushboilsbonebone bone marrow

bone marrow bone marrowcellularitybone marrowtransplant

bone pain

Index Term

Infection with unknown ANCInfection without neutropeniaHypertensionHypotensionHyperglycemiaHypoglycemiaVasculitisColitisDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyMelena/GI bleedingProctitisCataractGlaucomaVision-blurred visionFlushing Wound-infectiousOsteonecrosis (avascular necrosis)Tumor flareBone marrow cellularityHemoglobinFibrinogenBone marrow cellularity

Bilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyLeukocytes (total WBC)Neutrophils/granulocytes (ANC/AGC)PlateletsRash/desquamationStomatitis/pharyngitis (oral/pharyngeal mucositis)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: PlateletsTransfusion: pRBCsWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.Bone pain

Adverse Event

9001661781518349513920900107594018142900148

9001509001462119712992034110205941139311784425550182992375110640106172120310640

900160

900148

900150900146211971040757652004218204239521610

2374623748900134

16078

IMT Code

CTC Index Terms

bowel

bowel movementbowel obstruction

bowel perforationbowel resectionbowel wallthickeningbradycardia

bradypneabreastbreast developmentbreast enlargement

breast tendernessbreathing

breathlessbronchospasm

bruising

buffalo hump

bullaeburning

burning cTnIcTnT

Index Term

Abdominal pain or crampingColitisConstipationDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyMelena/GI bleedingRectal bleeding/hematocheziaConstipationFistula-intestinalIleus (or neuroconstipation)ColitisOperative injury of vein/arteryTyphlitis (inflammation of cecum)

Conduction abnormality/Atrioventricular heart blockHypothyroidismNodal/junctional arrhythmia/dysrhythmiaSinus bradycardiaLiver dysfunction/failure (clinical)GynecomastiaFeminization of maleFeminization of maleGynecomastiaGynecomastiaApneaFEV (1)Dyspnea (shortness of breath)Allergic reaction/hypersensitivity (including drug fever)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Bruising (in absence of grade 3 or 4 thrombocytopenia)DIC (disseminated intravascular coagulation)FibrinogenPartial thromboplastin time (PTT)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Rash/desquamationChest pain (non-cardiac and non-pleuritic)Dyspepsia/heartburnDysuria (painful urination)Vaginitis (not due to infection)Cardiac troponin I (cTnI)Cardiac troponin T (cTnT)

Adverse Event

1758081428174900148

90015090014621197129921208174221458269814290012623749

924010819041629883379611139811398961961213061247270519349104511991510400212031755521193

182041833017612706196672616826167

IMT Code

CTC Index Terms

calcium

calciuriacanalcancer

capillary

capillary leakcarbon dioxidecarbon monoxidecardiac

cardiac cardiac ischemiacardiac outputcardiac troponin

cardiac troponin I

cardiac troponin T

cardiovascular

carpopedal spasmcataractcatheter

cecumcellularitycellulitis

centripetal obesity

cerebrospinal fluidcerebrovascularcerebrovascularevent

chestchest pain

Index Term

HypercalcemiaHypocalcemiaUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)External Auditory CanalSecondary Malignancy-Other (Specify,____) excludes metastasis from initialprimaryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaAcute vascular leak syndromeFEV (1)Carbon monoxide diffusion capacity (DL(co))CPK (creatine phosphokinase)HypokalemiaSyncope (fainting)HyperkalemiaCardiac-ischemia/infarctionCardiac left ventricular functionCardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cardiac-ischemia/infarctionCardiac troponin I (cTnI)Cardiac-ischemia/infarctionCardiac troponin T (cTnT)Cardiac-ischemia/infarctionCPK (creatine phosphokinase)Syncope (fainting)HypocalcemiaCataractCatheter-related infectionHematuria (in the absence of vaginal bleeding)Urinary frequency/urgencyUrinary retention Typhlitis (inflammation of cecum)Bone marrow cellularityWound-infectiousWound-non-infectiousCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Arachnoiditis/meningismus/radiculitisCNS cerebrovascular ischemiaCNS hemorrhage/bleedingSyncope (fainting)PneumothoraxCardiac-ischemia/infarction

Adverse Event

5450545123355233551854900188

9001561779718640124722571811869545564325454966512152616826167966526168966526167966511869643254511020522932970258325852374910640255502555121193

103419572238266432211499665

IMT Code

CTC Index Terms

chest pain

chest tubechills

cholesterolcholeycystitischoreachronic pancreatitischylothoraxcirculatory failureclammy

clearanceclonicclotting

cloudy

cloudy lensclumsycluster coagulation

cognitive

Index Term

Chest pain (non-cardiac and non-pleuritic)CoughDyspepsia/heartburnMyocarditisPericardial effusion/pericarditisPleuritic painPneumothoraxArachnoiditis/meningismus/radiculitisFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCInfection without neutropeniaRigors, chillsHypercholesterolemiaBilirubinExtrapyramidal/involuntary movement/restlessnessPancreatitisLymphaticsPancreatitisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaCreatinineSeizure(s)Hematuria (in the absence of vaginal bleeding)Partial thromboplastin time (PTT)Phlebitis (superficial)Prothrombin time (PT)Thrombosis/embolismUrine color change (not related to other dietary or physiologic cause e.g.,bilirubin, concentrated urine, hematuria)CataractAtaxia (incoordination)HeadacheDIC (disseminated intravascular coagulation)EpistaxisFibrinogenHemorrhage/bleeding associated with surgeryLiver dysfunction/failure (clinical)Partial thromboplastin time (PTT)Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)Prothrombin time (PT)Cognitive disturbance/learning problems (for pediatrics)

Adverse Event

18330543176121821921219692114910341900162

900164

9001661781515337544921521110717234229587234900156177971162531509701755523815252731779815635

102051784699710400755212032151883371755593462527324832

IMT Code

CTC Index Terms

coituscold intolerancecolic

colitis

collagencollapsed lungcolor change

colostomy

coma

coma

communicationcompensated

compulsivebehaviorconcentration

Index Term

DyspareuniaHypothyroidismAbdominal pain or crampingColitisAbdominal pain or crampingAutoimmune reactionColitisDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCMelena/GI bleedingMucositis due to radiationPlateletsRectal bleeding/hematocheziaWeight lossAutoimmune reactionPneumothoraxUrine color change (not related to other dietary or physiologic cause e.g.,bilirubin, concentrated urine, hematuria)Diarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyProctitisCNS hemorrhage/bleedingHypothyroidismSIADH (syndrome of inappropriate antidiuretic hormone)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Arachnoiditis/meningismus/radiculitisDepressed level of consciousnessSpeech impairment (e.g., dysphasia or aphasia)Acidosis (metabolic or respiratory)Alkalosis (metabolic or respiratory)Mood alteration-euphoria

Mood alteration-anxiety, agitation

Adverse Event

1656110811758081421758046348142900148

90015090014621197900162

900164

9001661299184892004221202336846342114915635

900148

90015090014621197203412382610811132421610

103411740613353192811928313384

18122

IMT Code

CTC Index Terms

concentrationconductionabnormalityconductive hearinglossconfluent

confusion

congestive heartfailure

conjunctivaconjunctivitisconsciousnessconstipation

contractilityconvulsion

cord(s)corneacoronary

corticosteroidscoryzacough

crackles

cramping

Index Term

Mood alteration-euphoriaConduction abnormality/Atrioventricular heart block

Middle ear/hearing

Mucositis due to radiationRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Arachnoiditis/meningismus/radiculitisConfusionDepressed level of consciousnessHyperglycemiaMemory lossCardiac left ventricular functionDyspnea (shortness of breath)ConjunctivitisConjunctivitisSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)ColitisConstipationIleus (or neuroconstipation)HypercalcemiaDIC (disseminated intravascular coagulation)SIADH (syndrome of inappropriate antidiuretic hormone)Seizure(s)Injection site reactionKeratitis (corneal inflammation/corneal ulceration)Cardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cardiac-ischemia/infarctionSerum sicknessAllergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)CoughHemoptysisPneumonitis/pulmonary infiltratesPneumothoraxPulmonary fibrosisVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Adult respiratory distress syndrome (ARDS)CoughAbdominal pain or crampingDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomy

Adverse Event

133849240

18137

1848918490

1034118115174062090010298121570551351317943814281748269545010400113243150117231182261682616796651534719427543976860721149857110241861954317580900148

900150900146

IMT Code

CTC Index Terms

cramping

cranialcranial neuropathycreatinephosphakinasecreatinine

crisiscross matchedcrying

cutaneous lesionscutaneous striae

cyanosis

cyclescystitis

danger to self

deafnessdecreased venousreturndeep tendonreflexes

deep veinthombosisdeficit

dehydration

Index Term

Diarrhea patients without colostomyDysmenorrheaMyalgia (muscle pain)Pelvic painNeuropathy - cranialArachnoiditis/meningismus/radiculitisCPK (creatine phosphokinase)

HyperuricemiaThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Tumor flareTumor lysis syndromeHypertensionTransfusion: PlateletsIrritability (children <3 years of age)Mood alteration-depressionTearing (watery eyes)DIC (disseminated intravascular coagulation)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Adult respiratory distress syndrome (ARDS)CoughDyspnea (shortness of breath)Irregular menses (change from baseline)Bladder spasmsHematuria (in the absence of vaginal bleeding)Mood alteration-anxiety, agitationMood alteration-depressionMood alteration-euphoriaInner ear/hearingPortal vein flow

HypermagnesemiaHypocalcemiaThrombosis/embolism

Cognitive disturbance/learning problems (for pediatrics)Peripheral arterial ischemiaAcidosis (metabolic or respiratory)DehydrationDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomy

Adverse Event

21197700135513458228821034111869

1151021610

237512142818349237461807417644180841040021193

86195437052136321668970181221764413384192046061

11624545117798

2483217938192814966900148

90015090014621197

IMT Code

CTC Index Terms

dehydration

dejectiondelirium

delusional thinking

delusions

dementiadental depresseddepressiondermatitis

dermatomyositisdesquamation

destructiondiabetes

diabetes mellitus

diabeticdiabetic acidosisdialysis

diaphoresis

diarrhea

Index Term

HypercalcemiaVomitingWeight lossMood alteration-depressionConfusionDepressed level of consciousnessMood alteration-depressionMood alteration-euphoriaDelusionsHallucinationsConfusionHeadacheDepressed level of consciousnessMood alteration-depressionErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Hand-foot skin reactionRadiation dermatitisRash/desquamationAutoimmune reactionExternal Auditory CanalPhotosensitivityRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Rash/desquamationOsteonecrosis (avascular necrosis)CataractHyperglycemiaHypoglycemiaHyperglycemiaHypoglycemiaAcidosis (metabolic or respiratory)HypokalemiaHypermagnesemiaRenal failureThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Hot flashes/flushesHyperglycemiaHypoglycemiaSweating (diaphoresis)Colitis

Adverse Event

545021162233681764418115174061764413384134215376181159971740617644759

1747722047182044634185460002204718490

182041829910205209001075209001075192815455116241252421610

21193

5683209001075117858142

IMT Code

CTC Index Terms

diarrhea

dietdifficulty arousingdifficulty sleepingdifficultyswallowing

diffuse lowattenuationdiffuse white matternecrosisdiffusiondiminished skinturgordiplopiadirect antiglobulintestdisabling

discharge

discolorationdiscomfort

Index Term

DehydrationDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyPlateletsProctitisTyphlitis (inflammation of cecum)Weight lossConstipationDepressed level of consciousnessInsomniaDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationLeukoencephalopathy associated with radiological findings

Leukoencephalopathy associated with radiological findings

FEV (1)Dehydration

Vision-double vision (diplopia)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)

Ataxia (incoordination)Extrapyramidal/involuntary movement/restlessnessFatigue (lethargy, malaise, asthenia)Muscle weakness (not due to neuropathy)Myositis (inflammation/damage of muscle)Neuropathy - cranialNeuropathy - motorOsteonecrosis (avascular necrosis)Pyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)VertigoAllergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)ConjunctivitisEarache (otalgia)External Auditory CanalMiddle ear/hearingProctitisVaginitis (not due to infection)Nail changesChest pain (non-cardiac and non-pleuritic)

Adverse Event

4966900148

9001509001462119720042203412374923368817417406114014297993510110347

10347

124724966

63910451

17846110711423174011785422882181731829911033

209071942751370818541813720341196671317118330

IMT Code

CTC Index Terms

discomfort

disorientation

disruptivedisseminatedintravascularcoagulationdistention

distorted visiondisturbeddisturbed diuretics

diversiondiverticulitisdizziness

double vision

drainage

drainingdribbling

drooling

drug feverdrug-relatedhemolysis

Index Term

Gastric ulcer (requires radiographic or endoscopic documentation)GastritisConfusionDepressed level of consciousnessPersonality/behavioralDIC (disseminated intravascular coagulation)

Bladder spasmsFlatulenceUrinary frequency/urgencyUrinary retention CataractMood alteration-depressionMood alteration-euphoriaAscites (non-malignant)HypermagnesemiaHypokalemiaOperative injury to bladder and/or ureterColitisConduction abnormality/Atrioventricular heart blockDizziness/lightheadednessHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaHypotensionNodal/junctional arrhythmia/dysrhythmiaProlonged QTc interval (QTc > 0.48 seconds)Sinus bradycardiaSyncope (fainting)Vasovagal episodeVertigoNystagmusVertigoVision-double vision (diplopia)Pericardial effusion/pericarditisWound-infectiousWound-non-infectiousFistula or GU fistula (e.g., vaginal, vesicovaginal)IncontinenceUrinary retention CNS cerebrovascular ischemiaHypocalcemiaAllergic reaction/hypersensitivity (including drug fever)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)

Adverse Event

92392518115174061812410400

216688512583258510205176441338418111624545513962814292404640900156177975139904190786298643218500209072114320907639921225550255512375025842585957254511934910451

IMT Code

CTC Index Terms

dry eyedry mucousmembranesdry skin

dryness

ducts

duodenal ulcerduodenumdysdiadochokinesiadysentery

dysfunction

dysgeusiadysguesiadysmenorrheadysostosisdyspareuniadyspepsia

dysphagia

dysphasiadyspnea

dysrhythmia

Index Term

Dry eyeDehydration

DehydrationDry skinMouth drynessVaginal drynessLymphaticsSalivary gland changesDuodenal ulcer (requires radiographic or endoscopic documentation)Duodenal ulcer (requires radiographic or endoscopic documentation)Ataxia (incoordination)Diarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyPyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)Vaginal drynessTaste disturbance (dysgeusia)Mouth drynessDysmenorrheaUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Vaginal drynessAbdominal pain or crampingChest pain (non-cardiac and non-pleuritic)Dyspepsia/heartburnDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationHypocalcemiaMucositis due to radiationStomatitis/pharyngitis (oral/pharyngeal mucositis)Speech impairment (e.g., dysphasia or aphasia)Acute vascular leak syndromeAdult respiratory distress syndrome (ARDS)Allergic reaction/hypersensitivity (including drug fever)Cardiac left ventricular functionDIC (disseminated intravascular coagulation)Dyspnea (shortness of breath)HemoptysisPleural effusion (non-malignant)Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Hypokalemia

Adverse Event

237594966

496699551757419670229582208169169117846900148

9001509001462119711033

1967017407175747002335519670175801833017612142979935101545118489239513353186408619193491215104007059761967102415455

IMT Code

CTC Index Terms

dysrhythmia

dystonicear

ear painearache

eardrumecchymosis

eczema

edema

effusion

electrocardiogram

Index Term

Nodal/junctional arrhythmia/dysrhythmiaProlonged QTc interval (QTc > 0.48 seconds)Sinus bradycardiaSinus tachycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Syncope (fainting)Vasovagal episodeVentricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Extrapyramidal/involuntary movement/restlessnessExternal Auditory CanalInner ear/hearingEarache (otalgia)Earache (otalgia)Middle ear/hearingMiddle ear/hearingCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)DIC (disseminated intravascular coagulation)Allergic reaction/hypersensitivity (including drug fever)Dry skinAcute vascular leak syndromeAllergic reaction/hypersensitivity (including drug fever)Ascites (non-malignant)EdemaLymphaticsPortal vein flowProteinuriaRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Renal failureSerum sicknessStomatitis/pharyngitis (oral/pharyngeal mucositis)Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Weight gainWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.MyocarditisPericardial effusion/pericarditisPleural effusion (non-malignant)Conduction abnormality/Atrioventricular heart blockMyocarditisNodal/junctional arrhythmia/dysrhythmiaPericardial effusion/pericarditisProlonged QTc interval (QTc > 0.48 seconds)

Adverse Event

904190786298629717943643218500904311071185419204708708181371813721193

1040019349995518640193491811836022958606120652204718490

125241534723951024120938900134

18219212196792401821904192129078

IMT Code

CTC Index Terms

electrocardiogram

electrocauteryelectroencephalogramelectrolyte electrolyte balanceelectrolyte wastingembolism

emesis

emotional stressencephalopathy

endocrine

endoscopic

enemaenergyenlarged liverenteral support

enterocolitis

enzymes

epidermal

Index Term

Sinus bradycardiaSinus tachycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Hemorrhage/bleeding associated with surgeryLeukoencephalopathy associated with radiological findings

Tumor flareSIADH (syndrome of inappropriate antidiuretic hormone)Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Thrombosis/embolismThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)NauseaVomitingInsomniaLeukoencephalopathy associated with radiological findingsLiver dysfunction/failure (clinical)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Feminization of maleDuodenal ulcer (requires radiographic or endoscopic documentation)Gastric ulcer (requires radiographic or endoscopic documentation)ConstipationLibidoPortal vein flowDysphagia, esophagitis, odynophagia (painful swallowing)Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Stomatitis/pharyngitis (oral/pharyngeal mucositis)Febrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection without neutropeniaAmylaseCPK (creatine phosphokinase)GGT (Gamma-Glutamyl transpeptidase)Hepatic enlargementPancreatitisSGOT (AST) (serum glutamic oxaloacetic transaminase)SGPT (ALT) (serum glutamic pyruvic transaminase)Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal

Adverse Event

629862971794390432151810347

2375111324233551779821610

137721162114010347833721610

21193

1139869192381741750460611429759

2395900162

900164

17815213321186983758341723483778379759

IMT Code

CTC Index Terms

epidermalnecrolysisepigastricepigastric epilepsyepistaxiserection

eruption

erythema

erythematosiserythroderma

esophageal

esophageal varicesesophagitis

esophagoscopyesophagus

Index Term

necrolysis)

Dyspepsia/heartburnAbdominal pain or crampingSeizure(s)EpistaxisErectile impotenceLibidoErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Rash/desquamationArthritisCatheter-related infectionErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)External Auditory CanalHand-foot skin reactionInjection site reactionMucositis due to radiationPhlebitis (superficial)PhotosensitivityRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Rash/desquamationStomatitis/pharyngitis (oral/pharyngeal mucositis)Autoimmune reactionArthritisCatheter-related infectionErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)External Auditory CanalHand-foot skin reactionMucositis due to radiationPhlebitis (superficial)Rash/desquamationStomatitis/pharyngitis (oral/pharyngeal mucositis)Dysphagia-esophageal related to radiationFistula-esophagealFistula-intestinalMucositis due to radiationHematemesisDysphagia, esophagitis, odynophagia (painful swallowing)Mucositis due to radiationDysphagia-esophageal related to radiationDysphagia-esophageal related to radiation

Adverse Event

17612175803150755109417504759

182042089022932759

18541747711723184892381560002204718490

18204239546342089022932759

1854174771848923815182042395799320443221451848996514291848979937993

IMT Code

CTC Index Terms

esophagusestrogen

euphoriaevacuation

evisceration

excitabilityexfoliation

exfoliativedermatitis

expressionlessexpressive external auditorycanalexternal ear

extracellularextraduralextrapyramidalexudate

eye

eye dropseye pressureeyelidsfacial flushingfailure

fainting

Index Term

Fistula-esophagealGynecomastiaTumor flareMood alteration-euphoriaColitisConstipationWound-infectiousWound-non-infectiousHypercalcemiaHand-foot skin reactionRash/desquamationErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Rash/desquamationMood alteration-depressionSpeech impairment (e.g., dysphasia or aphasia)External Auditory Canal

External Auditory CanalRadiation dermatitisHypercalcemiaCNS hemorrhage/bleedingExtrapyramidal/involuntary movement/restlessnessPericardial effusion/pericarditisPleural effusion (non-malignant)CataractConjunctivitisDry eyeKeratitis (corneal inflammation/corneal ulceration)NystagmusPruritusTearing (watery eyes)Vision-flashing lights/floatersVision-night blindness (nyctalopia)Vision-photophobiaDry eyeGlaucomaConjunctivitisFlushing Adult respiratory distress syndrome (ARDS)Cardiac left ventricular functionCreatinineRenal failureUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Hypoglycemia

Adverse Event

20443961237511338481428174255502555154501747718204759

1820417644133531854

1854220475450238261107192121967102055132375911822114317781180849544140119462375994151317844861912151162512524233551075

IMT Code

CTC Index Terms

fainting

fallingfascial disruptionfascitis

fatigue

febrile neutropenia

feeding tube

feetfeminizationfever

fibrillation

fibrin splitfibrinogen

fibrosis

Index Term

Syncope (fainting)Vasovagal episodeVertigoAtaxia (incoordination)Wound-non-infectiousWound-infectiousWound-non-infectiousCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Fatigue (lethargy, malaise, asthenia)HypothyroidismMuscle weakness (not due to neuropathy)Febrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Typhlitis (inflammation of cecum)AnorexiaDysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationPeripheral arterial ischemiaFeminization of maleAllergic reaction/hypersensitivity (including drug fever)Arachnoiditis/meningismus/radiculitisCatheter-related infectionColitisEarache (otalgia)Febrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Fever (in the absence of neutropenia, where neutropenia is defined asAGC<1.0 x 10e9/L)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCInfection without neutropeniaMiddle ear/hearingPancreatitisRigors, chillsSerum sicknessTyphlitis (inflammation of cecum)Conduction abnormality/Atrioventricular heart blockSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)DIC (disseminated intravascular coagulation)DIC (disseminated intravascular coagulation)FibrinogenPulmonary fibrosis

Adverse Event

643218500209071784625551255502555121193

1423108117401900162

237491277993510117938113981934910341229328142708900162

6180

900164

900166178151813772341533715347237499240179431040010400212038571

IMT Code

CTC Index Terms

fine motorcoordinationfingernailfingersfissurefistula

flashing lightsflatulence

floatersfluidfluid around heartfluid balancefluid in lungs

fluid replacementfluid retention

fluid supportflushflushingflutter

focalfootforced expiratoryvolumeforceful vomitingforgetfulfracturesfrequency

Index Term

Pyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)Nail changesPeripheral arterial ischemiaProctitisDysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationFistula or GU fistula (e.g., vaginal, vesicovaginal)Fistula-esophagealFistula-intestinalFistula-pharyngealFistula-rectal/analOperative injury to bladder and/or ureterProctitisVision-flashing lights/floatersAbdominal pain or crampingFlatulenceVision-flashing lights/floatersLymphaticsPericardial effusion/pericarditisSIADH (syndrome of inappropriate antidiuretic hormone)Adult respiratory distress syndrome (ARDS)Pleural effusion (non-malignant)HypotensionAcute vascular leak syndromeWeight gainWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.Acute vascular leak syndromeHot flashes/flushesFlushing Conduction abnormality/Atrioventricular heart blockSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Seizure(s)Hand-foot skin reactionFEV (1)

VomitingMemory lossOsteonecrosis (avascular necrosis)Diarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomy

Adverse Event

11033

1317117938203417993510123750204432214590014210513962203419544175808519544229589212113248619196751391864020938900134

1864056831784492401794331501747712472

211621029818299900148

90015090014621197

IMT Code

CTC Index Terms

frequency

fretfulfullness

functional deficit

gait

galactorrhea

gasgastric ulcergastritis

giddinessgingivitisgirthglaucomaglottisglucose

glycerideglycosuriagraft-versus-host

grand malgranulocytes

grunting guiacgulletgum bleedinggynecomastia

hair growth

hair losshallucinations

Index Term

Dysuria (painful urination)ProctitisUrinary frequency/urgencyIrritability (children <3 years of age)Dyspepsia/heartburnEarache (otalgia)Urinary retention Peripheral arterial ischemiaVisceral arterial ischemia (non-myocardial)Ataxia (incoordination)VertigoFeminization of maleGynecomastiaFlatulenceGastric ulcer (requires radiographic or endoscopic documentation)Gastric ulcer (requires radiographic or endoscopic documentation)GastritisMucositis due to radiationMood alteration-euphoriaMucositis due to radiationAscites (non-malignant)GlaucomaVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)HyperglycemiaHypoglycemiaHypercholesterolemiaUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Bilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Seizure(s)Febrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Neutrophils/granulocytes (ANC/AGC)Adult respiratory distress syndrome (ARDS)Melena/GI bleedingDysphagia, esophagitis, odynophagia (painful swallowing)DIC (disseminated intravascular coagulation)GynecomastiaHypothyroidismCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)AlopeciaConfusionHallucinations

Adverse Event

70620341258318074176127082585179382616917846209071139896185192392392518489133841848918194110241209001075544923355900160

3150900162

576586191299142910400961108121193

77181155376

IMT Code

CTC Index Terms

halucinationshandhand flaphand-foot reactionhand-footsyndromehappinesshaptoglobin

hard stoolsharmful

headache

hearing

hearing

hearing hearing aidhearing loss

heart

heart attackheart attack

heart blockheart failure

Index Term

DelusionsHand-foot skin reactionLiver dysfunction/failure (clinical)Hand-foot skin reactionHand-foot skin reaction

Mood alteration-euphoriaAutoimmune reactionBilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.HaptoglobinHemoglobinHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)ColitisConfusionDelusionsHallucinationsArachnoiditis/meningismus/radiculitisEarache (otalgia)HeadacheHypoglycemiaMiddle ear/hearingExternal Auditory CanalInner ear/hearingMiddle ear/hearingNeuropathy - cranialMiddle ear/hearingNeuropathy - cranialInner ear/hearingInner ear/hearingHypothyroidismInner ear/hearingMiddle ear/hearingCPK (creatine phosphokinase)MyocarditisSyncope (fainting)Cardiac-ischemia/infarctionCardiac troponin I (cTnI)Cardiac troponin T (cTnT)Conduction abnormality/Atrioventricular heart blockCardiac left ventricular functionConduction abnormality/Atrioventricular heart block

Adverse Event

134211747783371747717477

13384463421521900160

20579106171045121610

8142181151342153761034170899710751813718541920418137228821813722882192041920410811920418137118691821643296652616826167924012159240

IMT Code

CTC Index Terms

heart failure

heartburn

helicobacter pyloriihelmet cells

hematemesis

hematochezia

hematuria

hemodialysishemoglobin

Index Term

MyocarditisNodal/junctional arrhythmia/dysrhythmiaProlonged QTc interval (QTc > 0.48 seconds)Sinus bradycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Vasovagal episodeVentricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Chest pain (non-cardiac and non-pleuritic)Duodenal ulcer (requires radiographic or endoscopic documentation)Dyspepsia/heartburnGastric ulcer (requires radiographic or endoscopic documentation)Duodenal ulcer (requires radiographic or endoscopic documentation)Autoimmune reactionBilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.HaptoglobinHemoglobinHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: pRBCsDIC (disseminated intravascular coagulation)GastritisHematemesisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaColitisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaRectal bleeding/hematocheziaWeight lossDysuria (painful urination)Hematuria (in the absence of vaginal bleeding)Hemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaRenal failureAutoimmune reactionHematemesisHematuria (in the absence of vaginal bleeding)HemoglobinHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)HemoptysisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopenia

Adverse Event

1821904190786298179431850090431833069117612923691463421521900160

20579106171045121610

23748104009259659001561779781429001561779721202336870697090015617797125244634965970106171045197690015617797

IMT Code

CTC Index Terms

hemoglobin

hemoglobinureahemolysis

hemolytic anemiahemolytic uremicsyndromehemoptysis

hemorrhage

Index Term

Melena/GI bleedingPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: pRBCsVaginal bleedingVomitingHemoglobinuriaAutoimmune reactionBilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.HaptoglobinHemoglobinHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: pRBCsHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)HemoptysisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaAutoimmune reactionBruising (in absence of grade 3 or 4 thrombocytopenia)CNS hemorrhage/bleedingColitisDIC (disseminated intravascular coagulation)Diarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyDuodenal ulcer (requires radiographic or endoscopic documentation)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationEpistaxisFibrinogenGastric ulcer (requires radiographic or endoscopic documentation)GastritisHematemesisHematuria (in the absence of vaginal bleeding)HemoglobinHemoptysisHemorrhage/bleeding associated with surgery

Adverse Event

1299934621610

2374817511211625371463421521900160

20579106171045121610

237481045121610

9769001561779746341991523826814210400900148

9001509001462119769179935101755212039239259659701061797621518

IMT Code

CTC Index Terms

hemorrhage

hemorrhage intoskinhemorrhagic stroke

hemorrhoids

hepatichepatic coma

hepaticencephalopathyhepatic enlargementhepatic failure

hepatitishepatitis hepatocellularinjury

hepatomegaly

hesitancyhiccoughshiccupshirsutism

Index Term

Hemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaMucositis due to radiationPartial thromboplastin time (PTT)PlateletsProctitisProthrombin time (PT)Transfusion: PlateletsTransfusion: pRBCsTyphlitis (inflammation of cecum)Vaginal bleedingVomitingPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)

Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)ProctitisRectal bleeding/hematocheziaRectal or perirectal pain (proctalgia)Hepatic painLiver dysfunction/failure (clinical)SGOT (AST) (serum glutamic oxaloacetic transaminase)SGPT (ALT) (serum glutamic pyruvic transaminase)Liver dysfunction/failure (clinical)

Hepatic enlargementAlkaline phosphataseGGT (Gamma-Glutamyl transpeptidase)Hepatic enlargementLiver dysfunction/failure (clinical)Liver dysfunction/failure (clinical)BilirubinAlkaline phosphataseGGT (Gamma-Glutamyl transpeptidase)SGOT (AST) (serum glutamic oxaloacetic transaminase)SGPT (ALT) (serum glutamic pyruvic transaminase)Hepatic enlargementLiver dysfunction/failure (clinical)Portal vein flowDysuria (painful urination)Hiccoughs (hiccups, singultus)Hiccoughs (hiccups, singultus)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Masculinization of female

Adverse Event

90015617797184891755520042203412527323746237482374917511211629346

21610

203412120830483658337837783798337

834117337837583418337833721521173378375837783798341833760617061034103421193

11358

IMT Code

CTC Index Terms

hives

hoarseness

hopelessnesshormonehormone imbalancehormoneshot flashhot flushhungerhydration

hyperactive reflexeshyperactivityhyperalimentation

hyperbilirubinemiahyperblirubinemia

hypercalcemia

hypercapneichyperchloremichypercholesterolemiahyperemesishyperglycemia

hyperkalemia

hypermagnesemiahypernatremiahyperpigmentation

Index Term

Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)PruritusUrticaria (hives, welts, wheals)HypothyroidismVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Mood alteration-depressionSIADH (syndrome of inappropriate antidiuretic hormone)GynecomastiaTumor flareHot flashes/flushesHot flashes/flushesHypoglycemiaDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)HypermagnesemiaStomatitis/pharyngitis (oral/pharyngeal mucositis)VomitingLiver dysfunction/failure (clinical)Mood alteration-anxiety, agitationDysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationBilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.HypercalcemiaTumor flareAcidosis (metabolic or respiratory)Acidosis (metabolic or respiratory)Hypercholesterolemia

NauseaCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)HyperglycemiaPancreatitisHyperkalemiaHyperuricemiaTumor lysis syndromeHypermagnesemiaHypernatremiaCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,

Adverse Event

759

1778122575108110241176441132496123751568356831075142979935101759

10451116242395211628337181227993510121521900160

54502375119281192815449

137721193

2090072345454115102142811624545221193

IMT Code

CTC Index Terms

hyperpigmentationhyperreflexia

hypersensitivity

hypertension

hypertensive crisishypertriglyceridemiahyperuricemiahypoalbuminemiahypocalcemia

hypocellularhypochloremichypocortisolism

hypogeusiahypoglycemiahypokalemia

hypomagnesemiahyponatremia

hypoperfusionhypophosphatemia

hypotension

Index Term

cutaneous striae)Arachnoiditis/meningismus/radiculitisPyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)Allergic reaction/hypersensitivity (including drug fever)Fever (in the absence of neutropenia, where neutropenia is defined asAGC<1.0 x 10e9/L)Radiation dermatitisRash/desquamationCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)HypertensionHypertensionHypertriglyceridemia

HyperuricemiaHypoalbuminemiaHypocalcemiaUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Bone marrow cellularityAlkalosis (metabolic or respiratory)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Taste disturbance (dysgeusia)HypoglycemiaAlkalosis (metabolic or respiratory)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)HypokalemiaNodal/junctional arrhythmia/dysrhythmiaHypomagnesmiaHyponatremiaSIADH (syndrome of inappropriate antidiuretic hormone)HypotensionHypophosphatemiaUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Autoimmune reactionColitisConduction abnormality/Atrioventricular heart blockDehydrationDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyFebrile neutropenia (fever of unknown origin without clinically or

Adverse Event

1034111033

193496180

220471820421193

183491834911490

1151019570545123355106401928321193

1740710751928321193

5455904119537545311324513911623233554634814292404966900148

90015090014621197900162

IMT Code

CTC Index Terms

hypotension

hypothermia

hypothyroidism

hypovolemic shock

hypoxemiahypoxia

Index Term

microbiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)HematemesisHematuria (in the absence of vaginal bleeding)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)HemoptysisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaHypotensionInfection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCInfection without neutropeniaNodal/junctional arrhythmia/dysrhythmiaPancreatitisPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Prolonged QTc interval (QTc > 0.48 seconds)Sinus bradycardiaSinus tachycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Syncope (fainting)Typhlitis (inflammation of cecum)Vaginal bleedingVentricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Weight lossFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCInfection without neutropeniaAutoimmune reactionHypothyroidismCNS hemorrhage/bleedingHematemesisHemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaMelena/GI bleedingPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Rectal bleeding/hematocheziaVaginal bleedingAdult respiratory distress syndrome (ARDS)Adult respiratory distress syndrome (ARDS)

Adverse Event

96597010451976900156177975139900164

900166178159041723493469078629862971794364322374917511904323368900162

900164

90016617815463410812382696597621518900156177971299934621201751186198619

IMT Code

CTC Index Terms

hypoxiaidiopathicthrombocytopenicpurpuraileumileus

imbalanceimmobilityimmune hemolyticanemiaimmunologicdisorderimmunosuppressiveimpairment

impotencyimpulsive behaviorinability toconcentrate

inability to sleepinactivityinappropriateantidiuretichormoneincisionincisional herniaincisionalseparationinconsolableincontinence

Index Term

HypoxiaAutoimmune reaction

Visceral arterial ischemia (non-myocardial)Abdominal pain or crampingColitisDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyIleus (or neuroconstipation)Typhlitis (inflammation of cecum)VertigoIleus (or neuroconstipation)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)

Serum sickness

Autoimmune reactionKeratitis (corneal inflammation/corneal ulceration)Mood alteration-depressionSpeech impairment (e.g., dysphasia or aphasia)Vision-blurred visionErectile impotenceMood alteration-euphoriaConfusionMood alteration-depressionMood alteration-anxiety, agitationMood alteration-depressionSIADH (syndrome of inappropriate antidiuretic hormone)

Wound-non-infectiousWound-non-infectiousWound-non-infectious

Irritability (children <3 years of age)Bladder spasmsCNS cerebrovascular ischemiaDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomy

Adverse Event

176394634

26169175808142900148

9001509001462119782692374920907826910451

15347

463411821764413353139311094133841811517644181221764411324

255512555125551

18074216689572900148

90015090014621197

IMT Code

CTC Index Terms

incontinence

incoordination

indigestion

indurationinfarction

infection

infectious colitis

infertileinfiltratesinflammation

Index Term

Fistula or GU fistula (e.g., vaginal, vesicovaginal)IncontinenceNeuropathy-sensoryAtaxia (incoordination)Neuropathy - cranialAbdominal pain or crampingChest pain (non-cardiac and non-pleuritic)Dyspepsia/heartburnInjection site reactionCPK (creatine phosphokinase)Cardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cardiac-ischemia/infarctionHypotensionBladder spasmsCatheter-related infectionEarache (otalgia)Gastric ulcer (requires radiographic or endoscopic documentation)Hematuria (in the absence of vaginal bleeding)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCInfection without neutropeniaMiddle ear/hearingTyphlitis (inflammation of cecum)Urinary frequency/urgencyWound-infectiousFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCMale infertilityPneumonitis/pulmonary infiltratesArthritisCatheter-related infectionConjunctivitisGastritisInjection site reactionKeratitis (corneal inflammation/corneal ulceration)MyocarditisMyositis (inflammation/damage of muscle)Pericardial effusion/pericarditisPhlebitis (superficial)

Adverse Event

23750258418172178462288217580183301761211723118692616826167966551392166822932708923970900164

900166178151813723749258325550900162

900164

9001661976286072089022932513925117231182182117854921223815

IMT Code

CTC Index Terms

inflammation

inflammation

inflammation inflammation ofesophagusinflammation ofpancreasinflammation ofstomachinflammatorybowel

inflammatorybowel diseaseinjection sitereaction

injuryinner earinsomnia

inspirationinsulinintercourse

intercranialpressureintestines

intracranialpressureintraocular pressureintubation

Index Term

Pleural effusion (non-malignant)Thrombosis/embolismTumor flareVaginitis (not due to infection)VasculitisVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Pneumonitis/pulmonary infiltratesTyphlitis (inflammation of cecum)Dysuria (painful urination)Dysphagia, esophagitis, odynophagia (painful swallowing)

Pancreatitis

Gastric ulcer (requires radiographic or endoscopic documentation)

Diarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyColitis

Injection site reactionPhlebitis (superficial)Thrombosis/embolismOperative injury of vein/arteryInner ear/hearingInsomniaMood alteration-anxiety, agitationMood alteration-depressionPleuritic painHypoglycemiaDyspareuniaErectile impotenceArachnoiditis/meningismus/radiculitis

Fistula-intestinalFistula-pharyngealIleus (or neuroconstipation)Arachnoiditis/meningismus/radiculitis

GlaucomaCardiac left ventricular functionPleural effusion (non-malignant)Stomatitis/pharyngitis (oral/pharyngeal mucositis)Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)

Adverse Event

19671779823751196679401102418607237497061429

7234

923

900148

900150900146211978142

11723238151779890012619204114018122176441969107516561109410341

22145900142826910341

94112151967239510241

IMT Code

CTC Index Terms

involuntaryinvoluntary involuntary eyemovementsinvoluntarymovementsirregular

irritability

irritable bowelsyndrome

irritation

ischemia

itching

jaundice

jaw pain

Index Term

TremorExtrapyramidal/involuntary movement/restlessnessNystagmus

Seizure(s)

Female sterilityIrregular menses (change from baseline)Arachnoiditis/meningismus/radiculitisIrritability (children <3 years of age)ColitisDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyConjunctivitisKeratitis (corneal inflammation/corneal ulceration)Vaginitis (not due to infection)CNS cerebrovascular ischemiaCPK (creatine phosphokinase)Cardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cardiac-ischemia/infarctionHypotensionOsteonecrosis (avascular necrosis)Peripheral arterial ischemiaSyncope (fainting)Visceral arterial ischemia (non-myocardial)Allergic reaction/hypersensitivity (including drug fever)BilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Hand-foot skin reactionLiver dysfunction/failure (clinical)PruritusRash/desquamationUrticaria (hives, welts, wheals)Vaginitis (not due to infection)BilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Liver dysfunction/failure (clinical)PancreatitisNeuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-

Adverse Event

25281107121143

3150

209302136310341180748142900148

9001509001462119751311821966795721186926168261679665513918299179386432261691934921521900160

1747783371778118204225751966721521900160

104518337723418654

IMT Code

CTC Index Terms

jaw painjoint

joint keratitis

kidney

kidney kidney failurekoilonychialack of appetitelactic acidlaryngospasm

larynx

laxatives

learning problemslenslesionlethargy

leukemia

leukocytes

leukoencepalopathyleukopenialevel ofconsciousness

light sensitivitylightheadedness

Index Term

infectious neuralgia, or painful neuropathies)ArthritisSerum sicknessArthralgia (joint pain)Dry eyeKeratitis (corneal inflammation/corneal ulceration)Dysuria (painful urination)HypercalcemiaHyperkalemiaHyponatremiaRenal failureProteinuriaHypermagnesemiaNail changesAnorexiaAcidosis (metabolic or respiratory)Allergic reaction/hypersensitivity (including drug fever)Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Mucositis due to radiationVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)ColitisConstipationCognitive disturbance/learning problems (for pediatrics)CataractGastric ulcer (requires radiographic or endoscopic documentation)Depressed level of consciousnessFatigue (lethargy, malaise, asthenia)HypomagnesmiaLiver dysfunction/failure (clinical)FibrinogenHemoglobinPartial thromboplastin time (PTT)PlateletsArachnoiditis/meningismus/radiculitisLeukocytes (total WBC)Leukoencephalopathy associated with radiological findingsAutoimmune reactionArachnoiditis/meningismus/radiculitisCNS hemorrhage/bleedingDepressed level of consciousnessSeizure(s)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)PhotosensitivityDizziness/lightheadedness

Adverse Event

2089015347460823759118270654505454545312524206511624131711271928119349102411848910241814281742483210205923174061423195378337212031061717555200421034110407103474634103412382617406315021610

60004640

IMT Code

CTC Index Terms

lightheadedness

lipase

lipidlipidslipsliquid diet

liver

liver dysfunctionliver enlargementliver failure

liver flaploss of appetite

loss ofconsciousness

loss ofconsiciousnessloss of deep tendonreflexesloss of kidneyloss of memoryloss of smellloss of vision

low phosphatelower GI bleedinglupuslymph nodeslymphaticslymphedemalymphopenialysis

Index Term

HypotensionNodal/junctional arrhythmia/dysrhythmiaSinus bradycardiaSyncope (fainting)Vasovagal episodeLipasePancreatitisHypercholesterolemiaLipaseMouth drynessDysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationHepatic enlargementHepatic painLiver dysfunction/failure (clinical)Liver dysfunction/failure (clinical)GGT (Gamma-Glutamyl transpeptidase)Liver dysfunction/failure (clinical)SGOT (AST) (serum glutamic oxaloacetic transaminase)SGPT (ALT) (serum glutamic pyruvic transaminase)Liver dysfunction/failure (clinical)AnorexiaPancreatitisCNS hemorrhage/bleedingDepressed level of consciousnessSyncope (fainting)Vasovagal episode

Neuropathy-sensory

Operative injury to bladder and/or ureterMemory lossSense of smellCataractGlaucomaKeratitis (corneal inflammation/corneal ulceration)Vision-night blindness (nyctalopia)HypophosphatemiaHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaAutoimmune reactionSerum sicknessLymphaticsLymphaticsLymphopeniaHyperuricemia

Adverse Event

513990416298643218500207737234544920773175747993510183418365833783378375833783778379833712772342382617406643218500

18172

13962102981022210205941118214011162390015646341534722958229581075111510

IMT Code

CTC Index Terms

lysismacularmagnesium

malabsorptionmalaise

malemale breastmale infertilitymalnutrition

mammary glandmasculinizationmastoiditis

megacolon

melena

memory memory loss

meningismusmenometrorrhagiamenopausemenorrhagia

menses

menstrual

menstrualirregularitiesmenstruationmental health mental retardation

Index Term

Tumor flareRash/desquamationHypermagnesemiaHypomagnesmiaHypomagnesmiaFatigue (lethargy, malaise, asthenia)Middle ear/hearingFeminization of maleGynecomastiaMale infertilityHypomagnesmiaWeight lossGynecomastiaMasculinization of femaleExternal Auditory CanalMiddle ear/hearingColitisConstipationAutoimmune reactionColitisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaMelena/GI bleedingWeight lossMemory lossCNS hemorrhage/bleedingConfusionMemory lossArachnoiditis/meningismus/radiculitisVaginal bleedingHot flashes/flushesHypothyroidismVaginal bleedingDysmenorrheaIrregular menses (change from baseline)Pelvic painVaginal bleedingDysmenorrheaPelvic painVaginal bleedingCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Irregular menses (change from baseline)Personality/behavioralCognitive disturbance/learning problems (for pediatrics)

Adverse Event

237511820411624195371953714231813711398961197621953723368961113581854181378142817446348142900156177971299233681029823826181151029810341175115683108117511700213631345817511700134581751121193

213631812424832

IMT Code

CTC Index Terms

mental statusmetabolic

metabolic metallic tastemicroangiopathy

middle earmigrainemilky pleuraleffusionmood

moon face

motion sicknessmotor

mouthmouth secretionsmouth sores

movementmovements

mucosa

mucositis

mucous colitismucous membranes

mucus

mucus stool

Index Term

Depressed level of consciousnessAlkalosis (metabolic or respiratory)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Acidosis (metabolic or respiratory)Salivary gland changesThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Middle ear/hearingHeadacheLymphatics

Mood alteration-anxiety, agitationMood alteration-depressionMood alteration-euphoriaCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)NauseaNeuropathy - motorPyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)Mouth drynessSalivary gland changesMucositis due to radiationStomatitis/pharyngitis (oral/pharyngeal mucositis)Seizure(s)Extrapyramidal/involuntary movement/restlessnessTremorMucositis due to radiationStomatitis/pharyngitis (oral/pharyngeal mucositis)DehydrationDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationMucositis due to radiationStomatitis/pharyngitis (oral/pharyngeal mucositis)ColitisAllergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)DehydrationErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Stomatitis/pharyngitis (oral/pharyngeal mucositis)ColitisProctitisColitisDiarrhea associated with graft versus host disease (GVHD) for BMT studies, if

Adverse Event

174061928321193

192812208121610

1813799722958

18122176441338421193

13771817311033

1757422081184892395315011071252818489239549661429799351011848923958142194274966759

23958142203418142900148

IMT Code

CTC Index Terms

mucus stool

muscle

muscle atrophymuscle damage

muscle rigiditymuscle spasmsmuscle wasting

muscle weakness

musculoskeletalmyalgiamyelophthisic

myelophthisic myocardialinfarction

myocarditismyocardiummyositismyxedema myxedema comanailnail changesnailbedsnailsnarcoticsnasal dischargenasal irritationnasal packingnasal stuffinessnausea

Index Term

specified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyMyalgia (muscle pain)Myositis (inflammation/damage of muscle)HypothyroidismCPK (creatine phosphokinase)Myositis (inflammation/damage of muscle)Extrapyramidal/involuntary movement/restlessnessHypocalcemiaCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)HypomagnesmiaMuscle weakness (not due to neuropathy)SIADH (syndrome of inappropriate antidiuretic hormone)CPK (creatine phosphokinase)Myalgia (muscle pain)FibrinogenPartial thromboplastin time (PTT)PlateletsHemoglobinCPK (creatine phosphokinase)Cardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cardiac-ischemia/infarctionHypotensionMyocarditisMyocarditisMyositis (inflammation/damage of muscle)HypothyroidismHypothyroidismNail changesNail changesNail changesNail changesRigors, chillsAllergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)EpistaxisEpistaxisAllergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)DIC (disseminated intravascular coagulation)Dyspepsia/heartburnGastritisHematemesis

Adverse Event

900150900146211971355178541081118691785411071545121193

1953717401113241186913552120317555200421061711869261682616796655139182118211785410811081131711317113171131711533719427755755194271040017612925965

IMT Code

CTC Index Terms

nausea

neck painnecrolysis

necrosis

necrotizingnecrotizingenterocolitis

necrotizing fascitis

nephropathynepthrostomy tubenervousnessneuro-cortical

Index Term

HypomagnesmiaIleus (or neuroconstipation)NauseaPancreatitisSIADH (syndrome of inappropriate antidiuretic hormone)VertigoVomitingArachnoiditis/meningismus/radiculitisErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)External Auditory CanalHematuria (in the absence of vaginal bleeding)Injection site reactionLeukoencephalopathy associated with radiological findingsMiddle ear/hearingMucositis due to radiationPeripheral arterial ischemiaProctitisRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Rash/desquamationSalivary gland changesStomatitis/pharyngitis (oral/pharyngeal mucositis)Typhlitis (inflammation of cecum)Wound-infectiousWound-non-infectiousVasculitisFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCTyphlitis (inflammation of cecum)Wound-infectiousWound-non-infectiousHypercalcemiaUreteral obstructionMood alteration-anxiety, agitationCNS cerebrovascular ischemiaNeuropathy - motorNeuropathy-sensoryPersonality/behavioral

Adverse Event

1953782691377723411324209072116210341759

759

18549701172310347181371848917938203412204718490

182042208123952374925550255519401900162

900164

900166237492555025551545020653181229572181731817218124

IMT Code

CTC Index Terms

neuro-corticalneuroconstipationneurologic pain

neuropathic pain

neuropathy

neutropenia

neutrophils

night blindnessnight visionnipple dischargenocturianocturnal stools

nodal rhythmnodesnon-myocardialischemianon-specificchangesnosenosebleednuccal rigiditynumbnessnutritional support

Index Term

Speech impairment (e.g., dysphasia or aphasia)Ileus (or neuroconstipation)Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies)Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies)Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies)Neuropathy - cranialNeuropathy - motorNeuropathy-sensoryFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCTyphlitis (inflammation of cecum)Febrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Neutrophils/granulocytes (ANC/AGC)Vision-night blindness (nyctalopia)Vision-night blindness (nyctalopia)GynecomastiaUrinary frequency/urgencyDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyNodal/junctional arrhythmia/dysrhythmiaLymphaticsVisceral arterial ischemia (non-myocardial)

Cardiac-ischemia/infarction

Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)EpistaxisArachnoiditis/meningismus/radiculitisNeuropathy-sensoryDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)ProctitisStomatitis/pharyngitis (oral/pharyngeal mucositis)

Adverse Event

13353826918654

18654

18654

228821817318172900162

900164

90016623749900162

5765140114019612583900148

9001509001462119790412295826169

9665

19427755103411817214297993759

203412395

IMT Code

CTC Index Terms

nyctalopianystagmusobesity

obstipation

obstruction

obstructive jaundice

obtundedocclusionodorodynophagia

olfactoryoliguria

oozing

opacityopaqueoperation

Index Term

Vision-night blindness (nyctalopia)NystagmusCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)ColitisConstipationIleus (or neuroconstipation)Abdominal pain or crampingColitisConstipationDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationDysuria (painful urination)Ileus (or neuroconstipation)Operative injury to bladder and/or ureterUreteral obstructionVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)BilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Liver dysfunction/failure (clinical)Depressed level of consciousnessOperative injury of vein/arterySense of smellDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationSense of smellDIC (disseminated intravascular coagulation)DehydrationRenal failureDIC (disseminated intravascular coagulation)FibrinogenPartial thromboplastin time (PTT)CataractCataractColitisDuodenal ulcer (requires radiographic or endoscopic documentation)Fistula or GU fistula (e.g., vaginal, vesicovaginal)Fistula-esophagealFistula-intestinalFistula-pharyngealFistula-rectal/analGastric ulcer (requires radiographic or endoscopic documentation)

Adverse Event

14012114321193

8142817482691758081428174142979935101706826913962206531024121521900160

83371740690012610222142979935101102221040049661252410400212031755510205102058142691237502044322145900142105923

IMT Code

CTC Index Terms

operation

operative injury

ophthalmologicchangesoral mucositis

orthostaticosteoarthritisosteonecrosisosteoporosis

otalgiaotitis

oxygen

pH highpH lowpRBC

Index Term

GastritisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaIleus (or neuroconstipation)Injection site reactionOperative injury of vein/arteryProctitisTyphlitis (inflammation of cecum)Visceral arterial ischemia (non-myocardial)Operative injury of vein/arteryOperative injury to bladder and/or ureterConjunctivitis

Mucositis due to radiationStomatitis/pharyngitis (oral/pharyngeal mucositis)HypotensionArthritisOsteonecrosis (avascular necrosis)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Earache (otalgia)Earache (otalgia)External Auditory CanalMiddle ear/hearingFEV (1)HypoxiaPleural effusion (non-malignant)Pneumonitis/pulmonary infiltratesPneumothoraxPulmonary fibrosisAlkalosis (metabolic or respiratory)Acidosis (metabolic or respiratory)Autoimmune reactionDehydrationGastric ulcer (requires radiographic or endoscopic documentation)GastritisHematemesisHematuria (in the absence of vaginal bleeding)HemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaMelena/GI bleedingProctitisRectal bleeding/hematochezia

Adverse Event

9259001561779782691172390012620341237492616990012613962513

1848923955139208901829921193

70870818541813712472176391967860721149857119283192814634496692392596597097621518900156177971299203412120

IMT Code

CTC Index Terms

pRBC

pad countpain

Index Term

Transfusion: pRBCsTyphlitis (inflammation of cecum)Vaginal bleedingVomitingVaginal bleedingAbdominal pain or crampingArachnoiditis/meningismus/radiculitisArthralgia (joint pain)ArthritisAscites (non-malignant)Bladder spasmsBone painCardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cardiac-ischemia/infarctionCatheter-related infectionChest pain (non-cardiac and non-pleuritic)ColitisConjunctivitisDIC (disseminated intravascular coagulation)DehydrationDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyDysmenorrheaDysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Gastric ulcer (requires radiographic or endoscopic documentation)GastritisHand-foot skin reactionHeadacheHepatic painInjection site reactionKeratitis (corneal inflammation/corneal ulceration)Mucositis due to radiationMyalgia (muscle pain)Myositis (inflammation/damage of muscle)Nail changesNeuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies)Pain due to radiation

Adverse Event

2374823749175112116217511175801034146082089018121668160782616826167966522932183308142513104004966900148

9001509001462119770079935101759

923925174779978365117231182184891355178541317118654

900180

IMT Code

CTC Index Terms

pain

pain due toradiationpainful swallowing

painful ulcerspalenesspallor

palpitations

palpitations palsypancreaspancreaticpancreatic enzymespancreatitis

papillomapapularparacentesisparalysis

paraplegia

Index Term

PancreatitisPeripheral arterial ischemiaPhotosensitivityPleuritic painPneumothoraxPortal vein flowProctitisRadiation dermatitisRectal or perirectal pain (proctalgia)Stomatitis/pharyngitis (oral/pharyngeal mucositis)Tumor flareTumor pain (onset or exacerbation of tumor pain due to treatment)Urinary retention Visceral arterial ischemia (non-myocardial)VomitingWeight lossPain due to radiation

Dysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationStomatitis/pharyngitis (oral/pharyngeal mucositis)Pigmentation changes (e.g., vitiligo)Hemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaNodal/junctional arrhythmia/dysrhythmiaPalpitationsSinus tachycardiaHypocalcemiaTremorPancreatitisAmylasePancreatitisAmylaseLipasePancreatitisVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Rash/desquamationAscites (non-malignant)CNS cerebrovascular ischemiaCNS hemorrhage/bleedingNeuropathy - motorPyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)Arachnoiditis/meningismus/radiculitis

Adverse Event

7234179386000196921149606120341220478304239523751239552585261692116223368900180

142979935101239517466900156177979041187762975451252872342133272342133220773723410241182041819572238261817311033

10341

IMT Code

CTC Index Terms

parasthesiaparathyroidparenteral support

paresthesiaparotidparotitisparoxysmalnocturnal dyspneapartial bowelobstructionpartialthromboplastin timepassed outpassing gaspatches

pathologic fracturespediatrics

peeling

Index Term

Neuropathy-sensoryHypomagnesmiaAnorexiaDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyDysphagia, esophagitis, odynophagia (painful swallowing)Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)HypomagnesmiaProctitisStomatitis/pharyngitis (oral/pharyngeal mucositis)VomitingHypocalcemiaSalivary gland changesAmylaseDyspnea (shortness of breath)

Ileus (or neuroconstipation)

Partial thromboplastin time (PTT)

Vasovagal episodeFlatulenceMucositis due to radiationPigmentation changes (e.g., vitiligo)Radiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Stomatitis/pharyngitis (oral/pharyngeal mucositis)Osteonecrosis (avascular necrosis)Bone marrow cellularityCognitive disturbance/learning problems (for pediatrics)Diarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyHypertensionHypotensionIrritability (children <3 years of age)Leukocytes (total WBC)Leukoencephalopathy associated with radiological findingsLymphopeniaHand-foot skin reaction

Adverse Event

1817219537127900148

900150900146211971429759

195372034123952116254512208121332705

8269

17555

18500851184891746618490

2395182991064024832900148

900150900146211971834951391807410407103471075117477

IMT Code

CTC Index Terms

peelingpelvic penile erectionpenispeptic ulcer

perforation

periarteritis nodosapericardial effusionpericardial sacpericardial windowpericarditisperiodperiod peripheral arterialdiseaseperipheral ischemiaperirectal abscessperirectal painperitonealperiumbilicalpersonalitypersonality changes

perspiration

petechiae

petit malphantom limb pain

pharyngeal

Index Term

PhotosensitivityPelvic painErectile impotenceLibidoDuodenal ulcer (requires radiographic or endoscopic documentation)Dyspepsia/heartburnGastric ulcer (requires radiographic or endoscopic documentation)ColitisDuodenal ulcer (requires radiographic or endoscopic documentation)Dysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationGastric ulcer (requires radiographic or endoscopic documentation)GastritisProctitisTyphlitis (inflammation of cecum)Autoimmune reactionPericardial effusion/pericarditisPericardial effusion/pericarditisPericardial effusion/pericarditisPericardial effusion/pericarditisDysmenorrheaPelvic painPeripheral arterial ischemia

Peripheral arterial ischemiaProctitisRectal or perirectal pain (proctalgia)ColitisAbdominal pain or crampingPersonality/behavioralCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Hot flashes/flushesSweating (diaphoresis)Bruising (in absence of grade 3 or 4 thrombocytopenia)Hemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Seizure(s)Neuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies)Dysphagia-pharyngeal related to radiationFistula-pharyngealMucositis due to radiation

Adverse Event

6000134581094175046911761292381426911429799351019239252034123749463492129212921292127001345817938

179382034183048142175801812421193

56831178519915900156177979346315018654

510190014218489

IMT Code

CTC Index Terms

pharyngealpharyngealmucositispharyngitis

pharynx

phlebitis

phosphatephosphaturiaphotophobia

photosensitivity

pigmentationchangespiles

pink eyepink urinepinnaepitting edema

platelets

Index Term

Stomatitis/pharyngitis (oral/pharyngeal mucositis)Dehydration

DehydrationDysphagia-pharyngeal related to radiationStomatitis/pharyngitis (oral/pharyngeal mucositis)Weight lossDysphagia-pharyngeal related to radiationFistula-pharyngealStomatitis/pharyngitis (oral/pharyngeal mucositis)Catheter-related infectionInjection site reactionPhlebitis (superficial)Thrombosis/embolismUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Arachnoiditis/meningismus/radiculitisVision-photophobiaArachnoiditis/meningismus/radiculitisPhotosensitivityPigmentation changes (e.g., vitiligo)

ProctitisRectal bleeding/hematocheziaRectal or perirectal pain (proctalgia)ConjunctivitisHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Radiation dermatitisEdemaPhotosensitivityRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Rash/desquamationAutoimmune reactionBruising (in absence of grade 3 or 4 thrombocytopenia)CNS hemorrhage/bleedingColitisDIC (disseminated intravascular coagulation)Diarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyEpistaxis

Adverse Event

23954966

496651012395233685101900142239522932117232381517798233552335510341194610341600017466

203412120830451310451220471836060002204718490

1820446341991523826814210400900148

90015090014621197755

IMT Code

CTC Index Terms

platelets

pleuralpleural effusion

pleural spacepleurisypleuriticpleuritic painpleurodyniapneumatosisintestinalis

pneumonia

pneumonitispneumothorax

polyarthritispoor wound healing

Index Term

Gastric ulcer (requires radiographic or endoscopic documentation)GastritisHematemesisHematuria (in the absence of vaginal bleeding)HemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaMelena/GI bleedingPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)PlateletsProctitisRectal bleeding/hematocheziaThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: PlateletsTyphlitis (inflammation of cecum)Vaginal bleedingVomitingPleural effusion (non-malignant)Dyspnea (shortness of breath)Pleural effusion (non-malignant)Weight gainWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.PneumothoraxPleuritic painPleuritic painChest pain (non-cardiac and non-pleuritic)Pleuritic painFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCTyphlitis (inflammation of cecum)HemoptysisPneumonitis/pulmonary infiltratesStomatitis/pharyngitis (oral/pharyngeal mucositis)Pneumonitis/pulmonary infiltratesDyspnea (shortness of breath)PneumothoraxArthralgia (joint pain)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)

Adverse Event

9239259659709762151890015617797129993462004220341212021610

237462374917511211621967705196720938900134

2114919691969183301969900162

900164

9001662374997686072395860770521149460821193

IMT Code

CTC Index Terms

poor wound healingportal hypertensionportal vein flowportal veinobstructionposition positive guiacpost-infectiousneuralgiapostictalpostnasal drippostural imbalancepotassium

pounding in chestprematurecontractionpressure

pro timeproctalgiaproctitis

projectileprolonged QTcintervalproprioceptionprotein

proteinuriaprothrombin timepruritis

pruritus

pryamidal tract

pseudocystspseudomembranousreactionpsychosis

pulmonary edema

Index Term

Wound-non-infectiousPortal vein flowPortal vein flowPortal vein flow

VertigoRectal bleeding/hematocheziaNeuropathic pain (e.g., jaw pain, neurologic pain, phantom limb pain, post-infectious neuralgia, or painful neuropathies)Seizure(s)Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)Ataxia (incoordination)HyperkalemiaHyperuricemiaHypokalemiaPalpitationsVentricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)

Chest pain (non-cardiac and non-pleuritic)HeadacheProthrombin time (PT)Rectal or perirectal pain (proctalgia)PlateletsProctitisVomitingProlonged QTc interval (QTc > 0.48 seconds)

Neuropathy-sensoryHypomagnesmiaProteinuriaProteinuriaProthrombin time (PT)BilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Renal failurePruritusRash/desquamationPyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)PancreatitisMucositis due to radiation

DelusionsHallucinationsAcute vascular leak syndrome

Adverse Event

25551606160616061

20907212018654

31501942717846545411510545518779043

183309972527383042004220341211629078

1817219537206520652527321521900160

12524177811820411033

723418489

13421537618640

IMT Code

CTC Index Terms

pulmonaryembolism

pulmonary failure

pulmonary fibrosispulse

purpura

purulent

pus

pyruiaradiation

radiation dermatitisradiation port

radiation recall

radiculitisradiographic

rales

Index Term

Dyspnea (shortness of breath)Thrombosis/embolismWeight gainWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.Pulmonary fibrosisNodal/junctional arrhythmia/dysrhythmiaPalpitationsAutoimmune reactionBruising (in absence of grade 3 or 4 thrombocytopenia)DIC (disseminated intravascular coagulation)FibrinogenHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaPartial thromboplastin time (PTT)Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)Prothrombin time (PT)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Catheter-related infectionWound-infectiousWound-non-infectiousCatheter-related infectionWound-infectiousWound-non-infectiousDysuria (painful urination)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationMucositis due to radiationPain due to radiationProctitisRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Stomatitis/pharyngitis (oral/pharyngeal mucositis)Typhlitis (inflammation of cecum)Radiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Radiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Arachnoiditis/meningismus/radiculitisDuodenal ulcer (requires radiographic or endoscopic documentation)Gastric ulcer (requires radiographic or endoscopic documentation)Pneumonitis/pulmonary infiltratesVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)

Adverse Event

7051779820938900134

8571904118774634199151040021203900156177971755593462527321610

2293225550255512293225550255517067993510118489900180203412204718490

2395237492204718490

18490

10341691923860710241

IMT Code

CTC Index Terms

rapid eyemovementsrapid pulse

rash

re-implantationreceptive rectal

rectal rectal bleeding

rectal painrectumred blood cells

red cell destructionred cell fragments

Index Term

Nystagmus

CNS hemorrhage/bleedingHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaMelena/GI bleedingPalpitationsRectal bleeding/hematocheziaSinus tachycardiaVaginal bleedingAllergic reaction/hypersensitivity (including drug fever)Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)PhotosensitivityRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Rash/desquamationSerum sicknessUrticaria (hives, welts, wheals)Operative injury to bladder and/or ureterSpeech impairment (e.g., dysphasia or aphasia)Fistula-rectal/analProctitisRectal bleeding/hematocheziaAutoimmune reactionColitisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaRectal or perirectal pain (proctalgia)Fistula-rectal/analHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Hemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Autoimmune reactionBilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: pRBCsWeight loss

Adverse Event

21143

2382690015612991877212062971751119349759

934660002204718490

182041534722575139621335310520341212046348142900156177978304105104519001561779721610

10451463421521900160

1045121610

2374823368

IMT Code

CTC Index Terms

red cell transfusionred eyeredness

refractorinessregional ileitisrenal

renal failure

renal insufficiency

renal tubularacidosis

renal tubularacidosis repair

resection

residualresidual hearinglossrespiration

Index Term

Transfusion: pRBCsConjunctivitisArthritisCatheter-related infectionExternal Auditory CanalFlushing Hand-foot skin reactionInjection site reactionMucositis due to radiationPhlebitis (superficial)PhotosensitivityRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Rash/desquamationStomatitis/pharyngitis (oral/pharyngeal mucositis)Thrombosis/embolismUrticaria (hives, welts, wheals)Transfusion: PlateletsColitisDysuria (painful urination)HyperuricemiaHyponatremiaRenal failureUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)HyperkalemiaThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Acidosis (metabolic or respiratory)HypophosphatemiaUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)

Operative injury of vein/arteryOperative injury to bladder and/or ureterOperative injury of vein/arteryVisceral arterial ischemia (non-myocardial)Urinary retention Middle ear/hearing

Acute vascular leak syndromeAdult respiratory distress syndrome (ARDS)ApneaCardiac left ventricular function

Adverse Event

2374851320890229321854178441747711723184892381560002204718490

1820423951779822575237468142706115105453125242335510451545421610

21610

192811162323355

9001261396290012626169258518137

186408619213061215

IMT Code

CTC Index Terms

respiration

respiratoryrespiratory respiratorycompromiserespiratorydifficultyrespiratory failurerespiratory functionrespiratory supportresting ejectionfractionrestlessnessretentionretinal changesretrogradereversalrheumatic painrheumatismrheumatoidrheumatoid arthritisrhinitis

rhonchi

rickettsridgingrigorsrub

sadnesssalivasalivary

salivary glandsalivationsaturationschistocytes

Index Term

HypermagnesemiaHypoxiaLiver dysfunction/failure (clinical)Pleural effusion (non-malignant)Pleuritic painPneumothoraxPulmonary fibrosisAcidosis (metabolic or respiratory)Alkalosis (metabolic or respiratory)Acute vascular leak syndrome

Ascites (non-malignant)

Cardiac left ventricular functionFEV (1)Cardiac left ventricular functionCardiac left ventricular function

Extrapyramidal/involuntary movement/restlessnessUrinary retention GlaucomaPortal vein flowPortal vein flowArthralgia (joint pain)Arthralgia (joint pain)ArthritisAutoimmune reactionAllergic reaction/hypersensitivity (including drug fever)Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)Adult respiratory distress syndrome (ARDS)CoughVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Urinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Nail changesRigors, chillsPericardial effusion/pericarditisPleural effusion (non-malignant)Mood alteration-depressionMouth drynessAmylaseSalivary gland changesSalivary gland changesSalivary gland changesHypoxiaAutoimmune reaction

Adverse Event

1162417639833719671969211498571192811928318640

181

12151247212151215

1107125859416061606146084608208904634193491942786195431024123355131711533792121967176441757421332220812208122081176394634

IMT Code

CTC Index Terms

schistocytes

sclerodermascratchingseasicknessseborrheic keratosissecond degreeblocksecondarymalignancysecretorysedationseizure

seizure(s)

senility

sense ofapprehensionsense of smellsensitivitysensorysensory dysfunctionsepsis

serous otitisserum sicknesssex

sexual pleasureshaking

Index Term

BilirubinBilirubin associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: pRBCsAutoimmune reactionPruritusNauseaKeratitis (corneal inflammation/corneal ulceration)Conduction abnormality/Atrioventricular heart block

Secondary Malignancy-Other (Specify,____) excludes metastasis from initialprimaryLymphaticsDepressed level of consciousnessCNS hemorrhage/bleedingSeizure(s)Arachnoiditis/meningismus/radiculitisCNS cerebrovascular ischemiaHypernatremiaLiver dysfunction/failure (clinical)SIADH (syndrome of inappropriate antidiuretic hormone)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)ConfusionMemory lossConfusion

Sense of smellPhotosensitivityNeuropathy-sensoryMood alteration-depressionCatheter-related infectionInfection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCInfection without neutropeniaOperative injury to bladder and/or ureterMiddle ear/hearingSerum sicknessDyspareuniaVaginal drynessLibidoExtrapyramidal/involuntary movement/restlessness

Adverse Event

21521900160

1045121610

23748463417781137711829240

900188

2295817406238263150103419572545283371132421610

181151029818115

102226000181721764422932900164

9001661781513962181371534716561196701750411071

IMT Code

CTC Index Terms

shaking

shock

shortness of breath

singultussinus sinus bradycardiasinus tachycardia

Index Term

Pyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)Rigors, chillsTremorCNS hemorrhage/bleedingCardiac left ventricular functionCatheter-related infectionConduction abnormality/Atrioventricular heart blockFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)HematemesisHematuria (in the absence of vaginal bleeding)HemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaHypotensionInfection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection with unknown ANCInfection without neutropeniaMelena/GI bleedingMyocarditisNodal/junctional arrhythmia/dysrhythmiaPancreatitisPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Prolonged QTc interval (QTc > 0.48 seconds)Rectal bleeding/hematocheziaSinus bradycardiaSinus tachycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Vaginal bleedingVentricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Adult respiratory distress syndrome (ARDS)Cardiac left ventricular functionDyspnea (shortness of breath)HypoxiaPalpitationsPneumothoraxPulmonary fibrosisHiccoughs (hiccups, singultus)HeadacheSinus bradycardiaSinus tachycardia

Adverse Event

11033

153372528238261215229329240900162

96597097621518900156177975139900164

900166178151299182190417234934690782120629862971794317511904386191215705176391877211498571103499762986297

IMT Code

CTC Index Terms

sinusitis

skeletal painskin

skin

skin creases

skin discolorationskin edema

skin folds

skin lesionsskin rash

skin turgor

sleepsleeplessness

smellsneezingsodium

somnolencesomnulencesore throat

soreness

spasms

Index Term

Allergic reaction/hypersensitivity (including drug fever)Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)Bone painDry skinHand-foot skin reactionInjection site reactionPhotosensitivityPigmentation changes (e.g., vitiligo)Urticaria (hives, welts, wheals)Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Radiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)PhotosensitivityPhotosensitivityRash/desquamationRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)DIC (disseminated intravascular coagulation)Allergic reaction/hypersensitivity (including drug fever)Serum sicknessDehydrationPruritusMood alteration-depressionInsomniaMood alteration-euphoriaSense of smellAllergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)HypernatremiaHyponatremiaSIADH (syndrome of inappropriate antidiuretic hormone)Depressed level of consciousnessHypothyroidismDysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationChest pain (non-cardiac and non-pleuritic)Myalgia (muscle pain)Pelvic painStomatitis/pharyngitis (oral/pharyngeal mucositis)Bladder spasmsCoughExtrapyramidal/involuntary movement/restlessnessHypothyroidism

Adverse Event

1934919427160789955174771172360001746622575759

2204718490

60006000182042204718490

10400193491534749661778117644114013384102221942754525453113241740610817993510118330135513458239521668543110711081

IMT Code

CTC Index Terms

spastic colonspeechspirometricmeasurementsspitting splenectomysplenomegaly

spottingsputumstaggeringstaggering gaitsteatorrheastentsterile

sterilitysteriods

steroids

sticky saliva stiff neckstiffnessstomach

stomach stomatitis

stool softenerstools

Index Term

ColitisSpeech impairment (e.g., dysphasia or aphasia)FEV (1)

HemoptysisHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Portal vein flowSerum sicknessVaginal bleedingHemoptysisVertigoAtaxia (incoordination)PancreatitisUreteral obstructionFemale sterilityMale infertilityFemale sterilityHemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)Pneumonitis/pulmonary infiltratesCataractSerum sicknessUrticaria (hives, welts, wheals)VasculitisSalivary gland changesArachnoiditis/meningismus/radiculitisMyalgia (muscle pain)Gastric ulcer (requires radiographic or endoscopic documentation)GastritisNauseaAbdominal pain or crampingDehydrationErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Mucositis due to radiationStomatitis/pharyngitis (oral/pharyngeal mucositis)Weight lossConstipationColitisConstipationDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyMelena/GI bleeding

Adverse Event

81421335312472

976104516061153471751197620907178467234206532093019762209301045186071020515347225759401220811034113559239251377175804966759

18489239523368817481428174900148

900150900146211971299

IMT Code

CTC Index Terms

stoolsstrabismusstressstriae

stridorstroke

stuffinessstumblingstupor

subarachnoidsubduralsublingualsubmandibularsuicidal ideation

suicidesunburnsuprapubicsupraventricularsurgery

Index Term

Rectal bleeding/hematocheziaNeuropathy - cranialIncontinenceCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)CNS cerebrovascular ischemiaCNS hemorrhage/bleedingHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaSyncope (fainting)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)Ataxia (incoordination)Arachnoiditis/meningismus/radiculitisDepressed level of consciousnessLiver dysfunction/failure (clinical)CNS hemorrhage/bleedingCNS hemorrhage/bleedingSalivary gland changesSalivary gland changesMood alteration-anxiety, agitationMood alteration-depressionMood alteration-depressionPhotosensitivityUrinary retention Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)ColitisDuodenal ulcer (requires radiographic or endoscopic documentation)Fistula or GU fistula (e.g., vaginal, vesicovaginal)Fistula-esophagealFistula-intestinalFistula-pharyngealFistula-rectal/analGastric ulcer (requires radiographic or endoscopic documentation)GastritisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaIleus (or neuroconstipation)Injection site reactionOperative injury of vein/arteryPeripheral arterial ischemiaProctitis

Adverse Event

212022882258421193

1024195722382690015617797643221610

194271784610341174068337238262382622081220811812217644176446000258517943814269123750204432214590014210592392521518900156177978269117239001261793820341

IMT Code

CTC Index Terms

surgery

suture repairswallow

sweating

swelling

syncope

Index Term

Typhlitis (inflammation of cecum)Ureteral obstructionVaginitis (not due to infection)Visceral arterial ischemia (non-myocardial)Operative injury of vein/arteryDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationNeuropathy - cranialStomatitis/pharyngitis (oral/pharyngeal mucositis)Hot flashes/flushesSweating (diaphoresis)Arthralgia (joint pain)ArthritisCatheter-related infectionEdemaHand-foot skin reactionAutoimmune reactionCNS cerebrovascular ischemiaCNS hemorrhage/bleedingColitisConduction abnormality/Atrioventricular heart blockDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyDizziness/lightheadednessFebrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)HematemesisHemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaHypotensionInfection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Infection without neutropeniaMelena/GI bleedingNodal/junctional arrhythmia/dysrhythmiaPancreatitisPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Prolonged QTc interval (QTc > 0.48 seconds)

Adverse Event

23749206531966726169900126142979935101228822395568311785460820890229321836017477463495722382681429240900148

900150900146211974640900162

96597621518900156177975139900164

1781512999041723493469078

IMT Code

CTC Index Terms

syncope

syndrome

syndrome ofinappropriateantidiuretichormonetachycardia

tachychardiatachypnea

talktamponadetarget lesions

taste

taste budstaste changes

taste disturbancetearing

Index Term

Rectal bleeding/hematocheziaSinus bradycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Syncope (fainting)Typhlitis (inflammation of cecum)Vaginal bleedingVentricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Acute vascular leak syndromeAdult respiratory distress syndrome (ARDS)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)DIC (disseminated intravascular coagulation)Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Hand-foot skin reactionHyperuricemiaSIADH (syndrome of inappropriate antidiuretic hormone)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Tumor flareTumor lysis syndromeUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)SIADH (syndrome of inappropriate antidiuretic hormone)

Sinus tachycardiaSupraventricular arrhythmias (SVT/atrial fibrillation/flutter)Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)PalpitationsAdult respiratory distress syndrome (ARDS)CoughPneumothoraxPulmonary fibrosisSpeech impairment (e.g., dysphasia or aphasia)Pericardial effusion/pericarditisErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Mouth drynessSalivary gland changesTaste disturbance (dysgeusia)Salivary gland changesSalivary gland changesTaste disturbance (dysgeusia)Taste disturbance (dysgeusia)Tearing (watery eyes)

Adverse Event

212062981794364322374917511904318640861921193

10400759

17477115101132421610

23751214282335511324

629717943904318778619543211498571133539212759

1757422081174072208122081174071740718084

IMT Code

CTC Index Terms

temperature

tenderness

tenesmustensiontetany

thin skin

third degree blockthirstthoracentesisthought processes

throat

throbbingthrombocytesthrombocytopenia

Index Term

Fever (in the absence of neutropenia, where neutropenia is defined asAGC<1.0 x 10e9/L)Rigors, chillsAbdominal pain or crampingCatheter-related infectionChest pain (non-cardiac and non-pleuritic)Injection site reactionPelvic painProctitisHeadacheHypocalcemiaHypomagnesmiaCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Conduction abnormality/Atrioventricular heart blockMouth drynessPleural effusion (non-malignant)Mood alteration-depressionMood alteration-euphoriaDysphagia, esophagitis, odynophagia (painful swallowing)Dysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationHeadachePlateletsAutoimmune reactionBruising (in absence of grade 3 or 4 thrombocytopenia)CNS hemorrhage/bleedingColitisDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyEpistaxisGastric ulcer (requires radiographic or endoscopic documentation)GastritisHematemesisHematuria (in the absence of vaginal bleeding)HemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaMelena/GI bleedingPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Platelets

Adverse Event

6180

1533717580229321833011723134582034199754511953721193

9240175741967176441338414297993510199720042463419915238268142900148

9001509001462119775592392596597097621518900156177971299934620042

IMT Code

CTC Index Terms

thrombocytopenia

thrombocytopenicpurpurathrombophlebitisthromboplastinthrombosis

thrombotic

thrombotic CVAthromboticmicroangiopathythyroidtidal volumetightnesstinglingtinnitus

tiredtoenailtoestonictotal WBCtotal white counttoxic epidermalnecrolysistoxic megacolon

tracheatransaminase

transfusion

Index Term

ProctitisRectal bleeding/hematocheziaThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: PlateletsTyphlitis (inflammation of cecum)Vaginal bleedingVomitingThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Phlebitis (superficial)Partial thromboplastin time (PTT)DIC (disseminated intravascular coagulation)Injection site reactionThrombosis/embolismThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)DIC (disseminated intravascular coagulation)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)CNS hemorrhage/bleedingThrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)HypothyroidismFEV (1)Chest pain (non-cardiac and non-pleuritic)Neuropathy-sensoryInner ear/hearingVertigoFatigue (lethargy, malaise, asthenia)Nail changesPeripheral arterial ischemiaSeizure(s)Leukocytes (total WBC)Leukocytes (total WBC)Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)ColitisConstipationVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)GGT (Gamma-Glutamyl transpeptidase)Liver dysfunction/failure (clinical)SGOT (AST) (serum glutamic oxaloacetic transaminase)SGPT (ALT) (serum glutamic pyruvic transaminase)Autoimmune reactionCNS hemorrhage/bleeding

Adverse Event

20341212021610

2374623749175112116221610

238151755510400117231779821610

1040021610

2382621610

108112472183301817219204209071423131711793831501040710407759

81428174102418375833783778379463423826

IMT Code

CTC Index Terms

transfusion

transfusion pRBCs

transfusion platelets

Index Term

ColitisDehydrationDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyEpistaxisGastric ulcer (requires radiographic or endoscopic documentation)GastritisHematemesisHematuria (in the absence of vaginal bleeding)Hemolysis (e.g., immune hemolytic anemia, drug related hemolysis, other)HemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaMelena/GI bleedingOperative injury of vein/arteryPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)PlateletsProctitisRectal bleeding/hematocheziaTransfusion: PlateletsTransfusion: pRBCsTyphlitis (inflammation of cecum)Vaginal bleedingVomitingEpistaxisHematemesisHematuria (in the absence of vaginal bleeding)HemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaPetechiae/purpura (hemorrhage/bleeding into skin or mucosa)Rectal bleeding/hematocheziaVaginal bleedingEpistaxisHematemesisHematuria (in the absence of vaginal bleeding)HemoptysisHemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopenia

Adverse Event

81424966900148

9001509001462119775592392596597010451976215189001561779712999001269346200422034121202374623748237491751121162755965970976215189001561779793462120175117559659709762151890015617797

IMT Code

CTC Index Terms

transfusion platelets

transient ischemicattack

transplant

transudatetremor

trigeminytriglycerides

trimustroponin

troponin Itroponin Ttruncal obesity

tumor

tumor flaretumor lysis tumor lysissyndrometumor paintunnel infectiontympanicmembranetyphlitis

Index Term

Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)Rectal bleeding/hematocheziaVaginal bleedingCNS cerebrovascular ischemiaSyncope (fainting)Diarrhea patients without colostomyLeukocytes (total WBC)Neutrophils/granulocytes (ANC/AGC)PlateletsRash/desquamationRenal failureStomatitis/pharyngitis (oral/pharyngeal mucositis)Thrombotic microangiopathy (e.g., thrombotic thrombocytopenic purpura/TTPor hemolytic uremic syndrome/HUS)Transfusion: PlateletsWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.Pleural effusion (non-malignant)Extrapyramidal/involuntary movement/restlessnessHypomagnesmiaPyramidal tract dysfunction (e.g., increased tone, hyperreflexia, positiveBabinski, decreased fine motor coordination)TremorVentricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)HypertriglyceridemiaPancreatitisHypocalcemiaCardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cardiac troponin I (cTnI)Cardiac troponin T (cTnT)Cushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Secondary Malignancy-Other (Specify,____) excludes metastasis from initialprimaryTumor flareTumor lysis syndromeTumor flareHyperuricemiaTumor lysis syndrome

Tumor pain (onset or exacerbation of tumor pain due to treatment)Catheter-related infectionMiddle ear/hearing

Abdominal pain or cramping

Adverse Event

93462120175119572643221197104075765200421820412524239521610

23746900134

1967110711953711033

2528904311490723454512616826167261682616721193

900188

2375121428237511151021428

239552293218137

17580

IMT Code

CTC Index Terms

typhlitis

ulcer

ulceratingdermatitisulceration

ulcerative colitisulcerativedermatitisunstable angina

upper GI bleed

uremic frostureter

urethrotomy

Index Term

Febrile neutropenia (fever of unknown origin without clinically ormicrobiologically documented infection) (ANC <1.0 x 10e9/L, fever >=38.5degrees C)Infection (documented clinically or microbiologically) with grade 3 or 4neutropenia (ANC <1.0 x 10e9/L)Melena/GI bleedingMucositis due to radiationPlateletsRectal bleeding/hematocheziaTyphlitis (inflammation of cecum)Abdominal pain or crampingDuodenal ulcer (requires radiographic or endoscopic documentation)HematemesisMelena/GI bleedingPlateletsRectal bleeding/hematocheziaStomatitis/pharyngitis (oral/pharyngeal mucositis)Erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)ColitisDysphagia-esophageal related to radiationDysphagia-pharyngeal related to radiationErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Gastric ulcer (requires radiographic or endoscopic documentation)Hematuria (in the absence of vaginal bleeding)Injection site reactionKeratitis (corneal inflammation/corneal ulceration)Mucositis due to radiationRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Rash/desquamationStomatitis/pharyngitis (oral/pharyngeal mucositis)Vaginitis (not due to infection)ColitisRash/desquamation

Cardiac troponin I (cTnI)Cardiac troponin T (cTnT)HematemesisHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaRenal failureOperative injury to bladder and/or ureterUreteral obstructionUrinary retention

Adverse Event

900162

900164

129918489200422120237491758069196512992004221202395759

814279935101759

923970117231182184892204718490

18204239519667814218204

26168261679659001561252413962206532585

IMT Code

CTC Index Terms

urge to defecateurgency

uric acidurinary electrolytewasting

urinationurine

urine osmolalityurticaria

vaginal bleeding

vaginal drynessvaginal fistulavaginitis

vaovagalvaricesvaricosityvascular eventvascular leak

vascular occlusionvasculitis

vasopressors

Index Term

ProctitisDiarrhea associated with graft versus host disease (GVHD) for BMT studies, ifspecified in the protocol.Diarrhea for pediatric BMT studies, if specified in the protocol.Diarrhea patients with a colostomyDiarrhea patients without colostomyDysuria (painful urination)Urinary frequency/urgencyHyperuricemiaHypokalemiaHypophosphatemiaDysuria (painful urination)CreatinineHematuria (in the absence of vaginal bleeding)IncontinenceProteinuriaUrinary electrolyte wasting (e.g., Fanconi's syndrome, renal tubular acidosis)Urinary retention Urine color change (not related to other dietary or physiologic cause e.g.,bilirubin, concentrated urine, hematuria)SIADH (syndrome of inappropriate antidiuretic hormone)Allergic reaction/hypersensitivity (including drug fever)Urticaria (hives, welts, wheals)Hemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopeniaVaginal bleedingVaginal drynessFistula or GU fistula (e.g., vaginal, vesicovaginal)Mucositis due to radiationVaginitis (not due to infection)Syncope (fainting)HematemesisRectal or perirectal pain (proctalgia)CNS hemorrhage/bleedingAcute vascular leak syndromeCardiac-ischemia/infarctionOperative injury of vein/arteryHand-foot skin reactionVasculitisCNS hemorrhage/bleedingHematemesisHematuria (in the absence of vaginal bleeding)Hemorrhage/bleeding associated with surgeryHemorrhage/bleeding with grade 3 or 4 thrombocytopeniaHemorrhage/bleeding without grade 3 or 4 thrombocytopenia

Adverse Event

20341900148

90015090014621197706258311510545511623706116259702584206523355258515635

1132419349225759001561779717511196702375018489196676432965830423826186409665900126174779401238269659702151890015617797

IMT Code

CTC Index Terms

vasopressors

vasovagalveinveno-occlusivedisease

ventilation

ventilation-perfusionventilatory support

ventriculararrhythmiaventriculartachycardia

ventriculomegalyvertigovesicovaginalvesicularviolent behavior

virilizationvisceravisceral arterialischemiavision

visual changes

visual disturbancevisual disturbancesvisual fieldsvisual impairment

Index Term

Melena/GI bleedingRectal bleeding/hematocheziaVasovagal episodeOperative injury of vein/arteryPortal vein flowWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.FEV (1)HypoxiaPneumonitis/pulmonary infiltratesPulmonary fibrosisFEV (1)

Acute vascular leak syndromeCardiac left ventricular functionVentricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)

Supraventricular arrhythmias (SVT/atrial fibrillation/flutter)Ventricular arrhythmia (PVCs/bigeminy/trigeminy/ventricular tachycardia)Leukoencephalopathy associated with radiological findingsVertigoFistula or GU fistula (e.g., vaginal, vesicovaginal)Rash/desquamationDelusionsHallucinationsMasculinization of femaleAbdominal pain or crampingVisceral arterial ischemia (non-myocardial)

CataractKeratitis (corneal inflammation/corneal ulceration)NystagmusVision-blurred visionVision-double vision (diplopia)Vision-flashing lights/floatersVision-night blindness (nyctalopia)Vision-photophobiaVision-blurred visionVision-flashing lights/floatersVision-night blindness (nyctalopia)Vision-photophobiaNeuropathy - cranialHypoglycemiaNeuropathy - cranialCataract

Adverse Event

12992120185009001266061900134

12472176398607857112472

1864012159043

17943904310347209072375018204134215376113581758026169

1020511822114313931639954414011946139319544140119462288210752288210205

IMT Code

CTC Index Terms

visual impairment

visual loss

vitamin Kdeficiencyvitiligo

vocalizevoice changes

voidingvomiting

vomiting bloodvomituswakefulnesswarmth

Index Term

ConjunctivitisGlaucomaVision-flashing lights/floatersVision-night blindness (nyctalopia)Vision-photophobiaCataractGlaucomaEpistaxis

Autoimmune reactionPigmentation changes (e.g., vitiligo)Voice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Masculinization of femaleVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Urinary frequency/urgencyArachnoiditis/meningismus/radiculitisDehydrationGastritisHematemesisHypomagnesmiaIleus (or neuroconstipation)NauseaPancreatitisPlateletsSIADH (syndrome of inappropriate antidiuretic hormone)VomitingWeight lossHematemesisVomitingInsomniaArthritisCatheter-related infectionErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)Hand-foot skin reactionInjection site reactionMucositis due to radiationPhlebitis (superficial)PhotosensitivityRadiation dermatitisRadiation recall reaction (reaction following chemotherapy in the absence ofadditional radiation therapy that occurs in a previous radiation port)Rash/desquamationStomatitis/pharyngitis (oral/pharyngeal mucositis)Thrombosis/embolism

Adverse Event

51394195441401194610205941755

463417466102411135810241258310341496692596519537826913777234200421132421162233689652116211402089022932759

1747711723184892381560002204718490

18204239517798

IMT Code

CTC Index Terms

water intoxicationwater retentionwatery eyesweakness

weight gain

weight loss

welts

whealswheeze

white blood cells

white count

white matterwithdrawnwork/schoolperformance

Index Term

SIADH (syndrome of inappropriate antidiuretic hormone)SIADH (syndrome of inappropriate antidiuretic hormone)Tearing (watery eyes)CNS cerebrovascular ischemiaCNS hemorrhage/bleedingCushingoid appearance (e.g., moon face, buffalo hump, centripetal obesity,cutaneous striae)Fatigue (lethargy, malaise, asthenia)HypoglycemiaHypokalemiaHypothyroidismMuscle weakness (not due to neuropathy)Myositis (inflammation/damage of muscle)Neuropathy - motorSyncope (fainting)Acute vascular leak syndromeAscites (non-malignant)EdemaHypothyroidismSIADH (syndrome of inappropriate antidiuretic hormone)Weight gainWeight gain - Veno-Occlusive Disease (VOD) for BMT studies if specified inthe protocol.ColitisVomitingWeight lossErythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermalnecrolysis)PruritusUrticaria (hives, welts, wheals)Urticaria (hives, welts, wheals)Adult respiratory distress syndrome (ARDS)CoughPulmonary fibrosisVoice changes/stridor/larynx (e.g., hoarseness, loss of voice, laryngitis)Arachnoiditis/meningismus/radiculitisLeukocytes (total WBC)LymphopeniaNeutrophils/granulocytes (ANC/AGC)Leukocytes (total WBC)Neutrophils/granulocytes (ANC/AGC)Leukoencephalopathy associated with radiological findingsMood alteration-depressionCognitive disturbance/learning problems (for pediatrics)

Adverse Event

11324113241808495722382621193

14231075545510811740117854181736432186401811836010811132420938900134

81422116223368759

17781225752257586195438571102411034110407107515765104075765103471764424832

IMT Code

CTC Index Terms

wound

wound separationxray

Index Term

Wound-infectiousWound-non-infectiousWound-non-infectiousPneumonitis/pulmonary infiltrates

Adverse Event

2555025551255518607

IMT Code


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