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RTOG 1010

Report Based on Data Through: 10/31/2014

A Phase III Trial Evaluating the Addition of Trastuzumab to Trimodality Treatment of HER2-

Overexpressing Esophageal Adenocarcinoma

STEP 1 REGISTRATION

↓

HER2 Testing

Mandatory submission of tissue for HER2 testing

NOTE: Tumor tissue must be received and patients must have confirmed HER2 positivity before randomization

can occur. Patients with confirmed HER2 negativity will not be randomized.

↓

STEP 2 REGISTRATION

STRATIFY

Presence of adenopathy: No vs. Yes—celiac absent vs. Yes—celiac present ≤ 2 cm

RANDOMIZE

↓ ↓

Arm 1

Radiation (50.4 Gy), paclitaxel, carboplatin, and

trastuzumab

Followed by surgery 5-8 weeks after completion of

radiation

Then maintenance trastuzumab, every 3 weeks for 13

treatments

Arm 2

Radiation (50.4 Gy), paclitaxel, and

carboplatin

Followed by surgery 5-8 weeks after

completion of radiation

Study Chairs: Medical Oncology

Howard Safran, M.D. (Principal Investigator) NRG Oncology

Lawrence Leichman, M.D. SWOG

Radiation Oncology

Theodore S. Hong, M.D. NRG Oncology

Michael Haddock, M.D. NRG Oncology

Thomas Dipetrillo, M.D. Alliance

Surgical Oncology

Carolyn Reed, M.D. Alliance


Correlative Science

Chandan Guha, M.D., Ph.D. NRG Oncology

Heinz Joseph Lenz, M.D. SWOG

Pathology

Murray Resnick, M.D., Ph.D. NRG Oncology

Translational

Ulrich Rodeck, M.D., Ph.D. NRG Oncology

Quality of Life

Lisa Kachnic, M.D. NRG Oncology

Protocol Statisticians: Kathryn Winter, M.S.

Jennifer Moughan, M.S.

Research Associates: Wendy Bergantz, R.N.

Debora Grant, R.N., M.S.N.

Dosimetrist: Susan McNulty, B.S., R.T. (R)(T), CMD

Activated: 12/30/2010

Status: Accruing

Objectives

Primary:

To determine if trastuzumab increases disease-free survival when combined with trimodality treatment

(radiation plus chemotherapy followed by surgery) for patients with HER2-overexpressing esophageal

adenocarcinoma

Secondary:

To evaluate if the addition of trastuzumab to trimodality treatment increases the pathologic complete response

rate and overall survival for patients with HER2-overexpressing esophageal adenocarcinoma.

To develop a tissue bank of tumor tissue from patients with non-metastatic esophageal adenocarcinoma.

To determine molecular correlates of complete pathologic response, disease-free survival, and overall survival

for patients with HER2 overexpressing esophageal adenocarcinoma treated with neoadjuvant and

maintenance trastuzumab.

To evaluate predictors of cardiotoxicity in patients with esophageal cancer treated with trastuzumab and

chemoradiation.

To evaluate adverse events associated with the addition of trastuzumab to trimodality treatment for patients

with non-metastatic esophageal adenocarcinoma.

Patient-Reported Quality of Life Objectives

To determine if the addition of trastuzumab to trimodality treatment improves the patient-reported Functional

Assessment of Cancer Therapy for Esophageal Cancer (FACT-E) Esophageal Cancer Subscale (ECS) score.


To determine if an improvement in the FACT-E ECS score at 6-8 weeks post completion of neoadjuvant

chemoradiation correlates with pathologic complete response.

To determine if pathologic complete response correlates with the FACT-E ECS score at 1 year and/or 2 years

from the start of chemoradiation.

To determine if the addition of trastuzumab to trimodality treatment improves the Swallow Index and Eating

Index Subscale scores of the FACT-E.

To determine if the addition of trastuzumab to paclitaxel, carboplatin, and radiation impacts quality-adjusted

survival

Patient Population

All patients must have pathologically confirmed adenocarcinoma of the esophagus that involves the mid (up to 25

cm), distal, or esophagogastric junction. The cancer may involve the stomach up to 5 cm. Patients must have an

endoscopy with biopsy and have the intention to submit tissue for central HER2 testing. Patients must have

disease stage T1N1-2, T2-3N0-2, according to the American Joint Committee on Cancer (AJCC) 7th edition

staging., Patients may have regional adenopathy including para-esophageal, gastric, gastrohepatic and celiac

nodes (Note: if celiac adenopathy is present, it must be ≤ 2 cm); and patients with tumors at the level of the carina

must undergo bronchoscopy to exclude fistula. All patients must be ≥ 18 years of age and have a Zubrod

performance status of 0-2. Prior to 2nd

step registration, all patients must have HER2 expressing adenocarcinoma

of the esophagus centrally assessed and patients must have LVEF ≥ institutional lower limit of normal by cardiac

echo or MUGA scan.

Summary

This is a randomized phase III study designed to assess the efficacy of trastuzumab for patients with HER2-

overexpressing (HER2+) esophageal adenocarcinoma. The primary endpoint for this study is disease-free

survival. Accrual was activated on December 30, 2010, and as of October 31, 2014, 156 HER2+ patients have

been randomized. The trial was recently amended to increase the sample size to 197 randomized HER2+ patients.

This was based on a prospective plan in the protocol to increase the sample size if the accrual was going well and

adverse events were acceptable, in order to detect a slightly smaller yet still clinically meaningful difference in

disease-free survival. The distributions by patient and tumor characteristics are shown in Tables 5 and 6. Median

(min-max) age is 63 years (24-83). As of October 31, 2014 the median time of follow-up for vital status is 11.7

months. AEs were graded with CTCAE version 4. As of October 31, 2014, there have been 19 patients (27.1%)

with reported grade 4 events and 4 (5.7%) with reported grade 5 events on the trastuzumab arm compared to 15

patients (22.4%) with reported grade 4 events and 3 (4.5%) with grade 5 events on the non-trastuzumab arm

(Table 7). Two of the grade 5 events on the trastuzumab arm are new as of this report, one unrelated and one

probably related to treatment. Two of the grade 5 events on the non-trastuzumab arm are new as of this report,

one possibly and one probably related to treatment (Table 10). The first interim analysis of efficacy is projected

for September 2015. The second interim analysis of toxicity is projected for February 2015.


Patient Accession Data

Cumulative Accrual for HER2 Status Assessment for RTOG 1010 - Data as of 10/31/2014

Table 1

RTOG 1010 Accrual for HER2 Status Assessment Summary – Data as of

10/31/2014

Date activated to accrual: December 30, 2010

Targeted sample size: 591

Projected monthly accrual: 9.9

Average monthly accrual over last 6 months: 8.3

Projected accrual as of 10/31/2014: 366

Total accrual as of 10/31/2014: 454

Percent of projected accrual achieved as of 10/31/2014: 124.04%

Percent of total targeted accrual as of 10/31/2014: 76.82%

0

75

150

225

300

375

450

525

600

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Month and Year

Projected Accrual

Observed Accrual

454

366


Cumulative Accrual for HER2+ Randomized for RTOG 1010 - Data as of 10/31/2014

Table 2

RTOG 1010 Accrual for HER2+ Randomized Summary - Data as of 10/31/2014

Date activated to accrual: December 30, 2010

Targeted sample size: 197

Projected monthly accrual: 3.4

Average monthly accrual over last 6 months: 3.5

Projected accrual as of 10/31/2014: 123

Total accrual as of 10/31/2014: 156

Percent of projected accrual achieved as of 10/31/2014: 126.83%

Percent of total targeted accrual as of 10/31/2014: 79.19%

Table 3

RTOG 1010 Accrual/Eligibility - Data as of 10/31/2014

RT+Paclitaxel+

Carboplatin+Trastuzumab

RT+Paclitaxel+

Carboplatin Total

Screened - - 454

Randomized 78 78 156

Ineligible 3 4 7

Eligible 75 74 149

0

50

100

150

200

Cum

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Ran

do

miz

ed

Month and Year

Projected Accrual

Observed Accrual

156

123


Table 4

RTOG 1010 Cases Excluded - Data as of 10/31/2014

RT+Paclitaxel+

Carboplatin+

Trastuzumab

(n=3)

RT+Paclitaxel+

Carboplatin

(n=4)

Total

(n=7)

Reason n % n % n %

Ineligible - H-P not done within specified window 1 33.3 2 50.0 3 42.9

Ineligible - Eligibility form >1 month overdue 1 33.3 0 0.0 1 14.3

Ineligible - Endoscopic ultrasound not done 0 0.0 1 25.0 1 14.3

Ineligible - PET-CT not done within specified window 1 33.3 0 0.0 1 14.3

Ineligible - T4 disease with proximal thoracic cancer 0 0.0 1 25.0 1 14.3

Patient Characteristics

Table 5

1st Step Registration

Patient and Tumor Characteristics for All Screened

Patients in RTOG 1010 - Data as of 10/31/2014

Patient or Tumor Characteristic n %

Age (years)

≤ 39 9 2.0

40 - 49 22 4.8

50 - 59 125 27.5

60-69 180 39.6

70-79 108 23.8

≥ 80 10 2.2

Gender

Male 412 90.7

Female 42 9.3

Race

American Indian or Alaska Native 3 0.7

Asian 5 1.1

Black or African American 9 2.0

White 429 94.5

Unknown 8 1.8

Ethnicity

Hispanic or Latino 16 3.5

Not Hispanic or Latino 426 93.8

Unknown 12 2.6

Total 454 100.0


Table 6

2nd

Step Randomization

Patient and Tumor Characteristics for All Eligible Patients with On-Study Data in

RTOG 1010 - Data as of 10/31/2014

RT+Paclitaxel+

Carboplatin+

Trastuzumab

RT+Paclitaxel

+Carboplatin Total

Patient or Tumor Characteristic n % n % n %

Age (years)

≤ 39 0 0.0 3 4.1 3 2.0

40 - 49 2 2.7 4 5.4 6 4.1

50 - 59 22 29.7 17 23.0 39 26.4

60-69 32 43.2 24 32.4 56 37.8

70-79 17 23.0 23 31.1 40 27.0

≥ 80 1 1.4 3 4.1 4 2.7

Gender

Male 67 90.5 62 83.8 129 87.2

Female 7 9.5 12 16.2 19 12.8

Race

American Indian or Alaska Native 0 0.0 1 1.4 1 0.7

Asian 2 2.7 0 0.0 2 1.4

Black or African American 1 1.4 0 0.0 1 0.7

White 71 95.9 72 97.3 143 96.6

Unknown 0 0.0 1 1.4 1 0.7

Ethnicity

Hispanic or Latino 1 1.4 4 5.4 5 3.4

Not Hispanic or Latino 72 97.3 69 93.2 141 95.3

Unknown 1 1.4 1 1.4 2 1.4

Zubrod Performance Status

0 50 67.6 48 64.9 98 66.2

1 23 31.1 23 31.1 46 31.1

2 1 1.4 3 4.1 4 2.7

T stage, clinical

T1 1 1.4 3 4.1 4 2.7

T2 13 17.6 11 14.9 24 16.2

T3 60 81.1 60 81.1 120 81.1

N stage, clinical

N0 19 25.7 22 29.7 41 27.7

N1 42 56.8 40 54.1 82 55.4

N2 13 17.6 12 16.2 25 16.9

M stage, clinical

M0 74 100.0 74 100.0 148 100.0


Table 6

2nd

Step Randomization

Patient and Tumor Characteristics for All Eligible Patients with On-Study Data in

RTOG 1010 - Data as of 10/31/2014

RT+Paclitaxel+

Carboplatin+

Trastuzumab

RT+Paclitaxel

+Carboplatin Total

Patient or Tumor Characteristic n % n % n %

Presence of Adenopathy

No 26 35.1 27 36.5 53 35.8

Yes adenopathy, but celiac absent 38 51.4 40 54.1 78 52.7

Yes adenopathy and celiac present ≤ 2 cm 10 13.5 7 9.5 17 11.5

Total 74 100.0 74 100.0 148 100.0

One eligible patient does not have on-study data and is excluded from this table.

Adverse Events

Table 7

Distribution of RTOG 1010 Patients by Highest Grade Adverse Event

by System Organ Class - Data as of 10/31/2014

Any Relationship to Protocol Treatment

RT+Paclitaxel+

Carboplatin+Trastuzumab (n=70) RT+Paclitaxel+Carboplatin (n=67)

System Organ Class n and (%) of Patients by Grade n and (%) of Patients by Grade

1 2 3 4 5 1 2 3 4 5

Overall Highest Grade 0 14 33 19 4 0 10 39 15 3

(0.0) (20.0) (47.1) (27.1) (5.7) (0.0) (14.9) (58.2) (22.4) (4.5)

Blood and lymphatic system

disorders

21 11 8 1 0

24 15 4 0 0

(30.0) (15.7) (11.4) (1.4) (0.0) (35.8) (22.4) (6.0) (0.0) (0.0)

Cardiac disorders 3 8 4 1 0 11 3 3 2 0

(4.3) (11.4) (5.7) (1.4) (0.0) (16.4) (4.5) (4.5) (3.0) (0.0)

Ear and labyrinth disorders 3 0 0 0 0 4 1 0 0 0

(4.3) (0.0) (0.0) (0.0) (0.0) (6.0) (1.5) (0.0) (0.0) (0.0)

Eye disorders 3 0 0 0 0 1 1 0 0 0

(4.3) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0) (0.0) (0.0)

Gastrointestinal disorders 18 28 18 2 0 18 28 16 1 0

(25.7) (40.0) (25.7) (2.9) (0.0) (26.9) (41.8) (23.9) (1.5) (0.0)

General disorders and

administration site conditions

28 23 4 1 2

14 30 6 0 2

(40.0) (32.9) (5.7) (1.4) (2.9) (20.9) (44.8) (9.0) (0.0) (3.0)

Hepatobiliary disorders 0 0 0 1 0 0 0 0 0 0

(0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Infections and infestations 1 11 8 6 0 0 6 8 1 1

(1.4) (15.7) (11.4) (8.6) (0.0) (0.0) (9.0) (11.9) (1.5) (1.5)


Table 7




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

Injury, poisoning and

procedural complications

9 3 2 0 0

10 1 1 1 0

(12.9) (4.3) (2.9) (0.0) (0.0) (14.9) (1.5) (1.5) (1.5) (0.0)

Investigations 8 18 23 14 0 4 26 25 12 0

(11.4) (25.7) (32.9) (20.0) (0.0) (6.0) (38.8) (37.3) (17.9) (0.0)

Metabolism and nutrition

disorders

18 23 12 1 0

11 19 20 0 0

(25.7) (32.9) (17.1) (1.4) (0.0) (16.4) (28.4) (29.9) (0.0) (0.0)

Musculoskeletal and connective

tissue disorders

11 5 2 0 0

6 10 3 0 0

(15.7) (7.1) (2.9) (0.0) (0.0) (9.0) (14.9) (4.5) (0.0) (0.0)

Nervous system disorders 21 5 3 0 0 13 11 3 1 0

(30.0) (7.1) (4.3) (0.0) (0.0) (19.4) (16.4) (4.5) (1.5) (0.0)

Psychiatric disorders 16 7 2 0 0 13 8 1 0 0

(22.9) (10.0) (2.9) (0.0) (0.0) (19.4) (11.9) (1.5) (0.0) (0.0)

Renal and urinary disorders 4 2 1 1 0 1 1 1 0 0

(5.7) (2.9) (1.4) (1.4) (0.0) (1.5) (1.5) (1.5) (0.0) (0.0)

Reproductive system and breast

disorders

0 0 0 0 0

0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Respiratory, thoracic and

mediastinal disorders

17 15 3 1 2

16 9 7 2 0

(24.3) (21.4) (4.3) (1.4) (2.9) (23.9) (13.4) (10.4) (3.0) (0.0)

Skin and subcutaneous tissue

disorders

22 5 0 0 0

13 5 2 0 0

(31.4) (7.1) (0.0) (0.0) (0.0) (19.4) (7.5) (3.0) (0.0) (0.0)

Surgical and medical

procedures

0 1 0 0 0

0 0 1 1 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0)

Vascular disorders 1 7 6 2 0 3 10 5 1 0

(1.4) (10.0) (8.6) (2.9) (0.0) (4.5) (14.9) (7.5) (1.5) (0.0)

Adverse events were graded with CTCAE version 4.0.


Table 8


by Specific Adverse Event Term - Data as of 10/31/2014


RT+Paclitaxel+


System Organ Class/Term n and (%) of Patients by Grade n and (%) of Patients by Grade

1 2 3 4 5 1 2 3 4 5

BLOOD AND

LYMPHATIC SYSTEM

DISORDERS

21 11 8 1 0

24 15 4 0 0

(30.0) (15.7) (11.4) (1.4) (0.0) (35.8) (22.4) (6.0) (0.0) (0.0)

Anemia 24 12 2 1 0 25 14 3 0 0

(34.3) (17.1) (2.9) (1.4) (0.0) (37.3) (20.9) (4.5) (0.0) (0.0)

Blood and lymphatic

system disorders - Other,

specify

1 0 2 0 0

3 1 0 0 0

(1.4) (0.0) (2.9) (0.0) (0.0) (4.5) (1.5) (0.0) (0.0) (0.0)

Febrile neutropenia 0 0 3 0 0 0 0 1 0 0

(0.0) (0.0) (4.3) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Leukocytosis 0 0 1 0 0 0 0 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Thrombotic

thrombocytopenic purpura

1 0 0 0 0

0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

CARDIAC DISORDERS 3 8 4 1 0 11 3 3 2 0

(4.3) (11.4) (5.7) (1.4) (0.0) (16.4) (4.5) (4.5) (3.0) (0.0)

Atrial fibrillation 0 2 1 0 0 0 1 0 1 0

(0.0) (2.9) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (1.5) (0.0)

Atrial flutter 0 0 2 0 0 0 0 1 0 0

(0.0) (0.0) (2.9) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Cardiac arrest 0 0 0 1 0 0 0 0 1 0

(0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0)

Cardiac disorders - Other,

specify

0 1 0 0 0

3 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (4.5) (0.0) (0.0) (0.0) (0.0)

Chest pain - cardiac 0 2 0 0 0 1 0 0 0 0

(0.0) (2.9) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Myocardial infarction 0 1 0 0 0 0 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Palpitations 1 0 0 0 0 1 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Pericardial effusion 0 2 0 0 0 0 1 0 0 0

(0.0) (2.9) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Pericarditis 0 0 0 0 0 1 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0) (0.0) (0.0)

Sinus bradycardia 1 0 0 0 0 1 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Sinus tachycardia 2 0 2 0 0 7 1 0 0 0

(2.9) (0.0) (2.9) (0.0) (0.0) (10.4) (1.5) (0.0) (0.0) (0.0)


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

Supraventricular

tachycardia

0 0 0 0 0

0 0 2 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (3.0) (0.0) (0.0)

Ventricular arrhythmia 0 0 0 0 0 0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Ventricular tachycardia 0 0 0 0 0 0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

EAR AND LABYRINTH

DISORDERS

3 0 0 0 0

4 1 0 0 0

(4.3) (0.0) (0.0) (0.0) (0.0) (6.0) (1.5) (0.0) (0.0) (0.0)

Ear and labyrinth

disorders - Other, specify

0 0 0 0 0

1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Hearing impaired 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Tinnitus 2 0 0 0 0 2 1 0 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (3.0) (1.5) (0.0) (0.0) (0.0)

Vertigo 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

EYE DISORDERS 3 0 0 0 0 1 1 0 0 0

(4.3) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0) (0.0) (0.0)

Blurred vision 1 0 0 0 0 0 1 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Eye disorders - Other,

specify

1 0 0 0 0

1 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Floaters 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

GASTROINTESTINAL

DISORDERS

18 28 18 2 0

18 28 16 1 0

(25.7) (40.0) (25.7) (2.9) (0.0) (26.9) (41.8) (23.9) (1.5) (0.0)

Abdominal distension 0 1 0 0 0 0 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Abdominal pain 10 6 0 0 0 9 3 4 0 0

(14.3) (8.6) (0.0) (0.0) (0.0) (13.4) (4.5) (6.0) (0.0) (0.0)

Bloating 1 0 0 0 0 3 2 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (4.5) (3.0) (0.0) (0.0) (0.0)

Constipation 15 4 0 0 0 18 8 0 0 0

(21.4) (5.7) (0.0) (0.0) (0.0) (26.9) (11.9) (0.0) (0.0) (0.0)

Diarrhea 16 8 4 0 0 19 4 1 0 0

(22.9) (11.4) (5.7) (0.0) (0.0) (28.4) (6.0) (1.5) (0.0) (0.0)

Dry mouth 2 0 0 0 0 3 1 0 0 0


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

(2.9) (0.0) (0.0) (0.0) (0.0) (4.5) (1.5) (0.0) (0.0) (0.0)

Duodenal perforation 0 0 0 0 0 0 0 0 1 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0)

Duodenal stenosis 0 0 0 0 0 0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Dyspepsia 10 5 1 0 0 6 5 0 0 0

(14.3) (7.1) (1.4) (0.0) (0.0) (9.0) (7.5) (0.0) (0.0) (0.0)

Dysphagia 19 18 4 0 0 8 18 5 0 0

(27.1) (25.7) (5.7) (0.0) (0.0) (11.9) (26.9) (7.5) (0.0) (0.0)

Esophageal hemorrhage 0 0 1 0 0 0 1 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Esophageal obstruction 0 0 0 0 0 0 0 1 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Esophageal pain 4 6 0 0 0 5 4 0 0 0

(5.7) (8.6) (0.0) (0.0) (0.0) (7.5) (6.0) (0.0) (0.0) (0.0)

Esophageal perforation 0 0 0 1 0 0 0 0 0 0

(0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Esophageal stenosis 0 1 2 0 0 0 1 1 0 0

(0.0) (1.4) (2.9) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0) (0.0)

Esophageal ulcer 0 0 0 0 0 0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Esophagitis 14 19 5 0 0 15 13 2 0 0

(20.0) (27.1) (7.1) (0.0) (0.0) (22.4) (19.4) (3.0) (0.0) (0.0)

Flatulence 2 0 0 0 0 1 0 0 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Gastric hemorrhage 0 0 1 0 0 0 0 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Gastric perforation 0 0 1 0 0 0 0 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Gastric ulcer 0 1 1 0 0 0 0 0 0 0

(0.0) (1.4) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Gastritis 1 1 0 0 0 0 0 0 0 0

(1.4) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Gastroesophageal reflux

disease

6 7 0 0 0

2 1 0 0 0

(8.6) (10.0) (0.0) (0.0) (0.0) (3.0) (1.5) (0.0) (0.0) (0.0)

Gastrointestinal disorders -

Other, specify

3 2 3 0 0

4 3 1 0 0

(4.3) (2.9) (4.3) (0.0) (0.0) (6.0) (4.5) (1.5) (0.0) (0.0)

Gastrointestinal pain 3 1 0 0 0 0 0 0 0 0

(4.3) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Gastroparesis 0 0 0 0 0 0 1 0 0 0


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Hemorrhoids 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Ileus 0 1 0 0 0 0 0 1 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Intra-abdominal

hemorrhage

0 0 1 0 0

0 0 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Malabsorption 0 1 0 0 0 0 1 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Mucositis oral 6 1 0 0 0 8 3 0 0 0

(8.6) (1.4) (0.0) (0.0) (0.0) (11.9) (4.5) (0.0) (0.0) (0.0)

Nausea 24 9 9 0 0 25 17 6 0 0

(34.3) (12.9) (12.9) (0.0) (0.0) (37.3) (25.4) (9.0) (0.0) (0.0)

Obstruction gastric 0 0 0 1 0 0 1 0 0 0

(0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Oral pain 1 0 0 0 0 2 1 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (3.0) (1.5) (0.0) (0.0) (0.0)

Rectal hemorrhage 1 0 1 0 0 1 0 0 0 0

(1.4) (0.0) (1.4) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Rectal pain 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Salivary duct

inflammation

1 0 0 0 0

0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Small intestinal

obstruction

0 0 1 0 0

0 0 1 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Stomach pain 1 0 0 0 0 0 3 1 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (4.5) (1.5) (0.0) (0.0)

Vomiting 12 5 1 0 0 16 7 3 0 0

(17.1) (7.1) (1.4) (0.0) (0.0) (23.9) (10.4) (4.5) (0.0) (0.0)

GENERAL DISORDERS

AND ADMINISTRATION

SITE CONDITIONS

28 23 4 1 2

14 30 6 0 2

(40.0) (32.9) (5.7) (1.4) (2.9) (20.9) (44.8) (9.0) (0.0) (3.0)

Chills 8 1 0 0 0 7 1 0 0 0

(11.4) (1.4) (0.0) (0.0) (0.0) (10.4) (1.5) (0.0) (0.0) (0.0)

Death NOS 0 0 0 0 1 0 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0)

Edema limbs 4 1 0 0 0 4 0 0 0 0

(5.7) (1.4) (0.0) (0.0) (0.0) (6.0) (0.0) (0.0) (0.0) (0.0)


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

Fatigue 30 20 3 0 0 16 25 5 0 0

(42.9) (28.6) (4.3) (0.0) (0.0) (23.9) (37.3) (7.5) (0.0) (0.0)

Fever 6 2 2 0 0 6 2 0 0 0

(8.6) (2.9) (2.9) (0.0) (0.0) (9.0) (3.0) (0.0) (0.0) (0.0)

Flu like symptoms 2 1 0 0 0 1 0 0 0 0

(2.9) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Gait disturbance 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)


administration site

conditions - Other, specify

3 0 1 0 0

0 1 0 0 0

(4.3) (0.0) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Infusion related reaction 1 3 0 1 0 1 3 1 0 0

(1.4) (4.3) (0.0) (1.4) (0.0) (1.5) (4.5) (1.5) (0.0) (0.0)

Localized edema 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Malaise 2 0 0 0 0 0 0 0 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Multi-organ failure 0 0 0 0 0 0 0 0 0 2

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (3.0)

Non-cardiac chest pain 2 3 1 0 0 1 2 0 0 0

(2.9) (4.3) (1.4) (0.0) (0.0) (1.5) (3.0) (0.0) (0.0) (0.0)

Pain 6 6 0 0 0 5 7 0 0 0

(8.6) (8.6) (0.0) (0.0) (0.0) (7.5) (10.4) (0.0) (0.0) (0.0)

Sudden death NOS 0 0 0 0 1 0 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0)

HEPATOBILIARY

DISORDERS

0 0 0 1 0

0 0 0 0 0

(0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Hepatic failure 0 0 0 1 0 0 0 0 0 0

(0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

INFECTIONS AND

INFESTATIONS

1 11 8 6 0

0 6 8 1 1

(1.4) (15.7) (11.4) (8.6) (0.0) (0.0) (9.0) (11.9) (1.5) (1.5)

Bladder infection 0 1 0 0 0 0 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Catheter related infection 0 1 2 0 0 0 0 2 0 0

(0.0) (1.4) (2.9) (0.0) (0.0) (0.0) (0.0) (3.0) (0.0) (0.0)

Esophageal infection 0 1 0 0 0 0 1 1 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0) (0.0)

Infections and infestations

- Other, specify

0 1 2 0 0

0 0 1 0 0


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

(0.0) (1.4) (2.9) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Lung infection 0 0 3 1 0 0 3 4 0 0

(0.0) (0.0) (4.3) (1.4) (0.0) (0.0) (4.5) (6.0) (0.0) (0.0)

Mediastinal infection 0 0 1 0 0 0 0 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Mucosal infection 1 0 1 0 0 1 0 0 0 0

(1.4) (0.0) (1.4) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Papulopustular rash 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Pleural infection 0 1 0 0 0 0 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Rhinitis infective 0 1 0 0 0 0 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Sepsis 0 0 0 5 0 0 0 0 1 1

(0.0) (0.0) (0.0) (7.1) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5)

Sinusitis 0 2 0 0 0 0 1 0 0 0

(0.0) (2.9) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Skin infection 1 0 0 0 0 0 2 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (3.0) (0.0) (0.0) (0.0)

Stoma site infection 0 1 1 0 0 0 1 0 0 0

(0.0) (1.4) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Upper respiratory

infection

0 4 0 0 0

0 1 0 0 0

(0.0) (5.7) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Urinary tract infection 0 2 1 0 0 0 0 1 0 0

(0.0) (2.9) (1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Wound infection 0 0 0 0 0 0 0 1 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

INJURY, POISONING

AND PROCEDURAL

COMPLICATIONS

9 3 2 0 0

10 1 1 1 0

(12.9) (4.3) (2.9) (0.0) (0.0) (14.9) (1.5) (1.5) (1.5) (0.0)

Bruising 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Dermatitis radiation 7 0 0 0 0 7 0 0 0 0

(10.0) (0.0) (0.0) (0.0) (0.0) (10.4) (0.0) (0.0) (0.0) (0.0)

Esophageal anastomotic

leak

0 1 0 0 0

0 0 1 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Fall 0 1 0 0 0 1 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Fracture 0 1 1 0 0 0 0 0 0 0


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

(0.0) (1.4) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Gastrointestinal

anastomotic leak

0 0 0 0 0

0 0 0 1 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0)

Radiation recall reaction

(dermatologic)

2 0 0 0 0

3 0 0 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (4.5) (0.0) (0.0) (0.0) (0.0)

Seroma 0 0 0 0 0 0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Tracheal hemorrhage 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Wound dehiscence 0 0 1 0 0 0 0 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

INVESTIGATIONS 8 18 23 14 0 4 26 25 12 0

(11.4) (25.7) (32.9) (20.0) (0.0) (6.0) (38.8) (37.3) (17.9) (0.0)

Activated partial

thromboplastin time

prolonged

0 0 0 0 0

1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Alanine aminotransferase

increased

6 1 0 0 0

6 0 0 0 0

(8.6) (1.4) (0.0) (0.0) (0.0) (9.0) (0.0) (0.0) (0.0) (0.0)

Alkaline phosphatase

increased

5 0 0 0 0

4 0 0 0 0

(7.1) (0.0) (0.0) (0.0) (0.0) (6.0) (0.0) (0.0) (0.0) (0.0)

Aspartate

aminotransferase

increased

10 1 0 0 0

5 1 0 0 0

(14.3) (1.4) (0.0) (0.0) (0.0) (7.5) (1.5) (0.0) (0.0) (0.0)

Blood bilirubin increased 3 1 0 0 0 4 1 0 0 0

(4.3) (1.4) (0.0) (0.0) (0.0) (6.0) (1.5) (0.0) (0.0) (0.0)

CD4 lymphocytes

decreased

0 0 0 0 0

0 0 2 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (3.0) (0.0) (0.0)

Cardiac troponin I

increased

0 0 0 0 0

1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Cholesterol high 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Creatinine increased 1 0 0 0 0 4 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (6.0) (0.0) (0.0) (0.0) (0.0)


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

Ejection fraction

decreased

0 2 0 0 0

0 0 1 0 0

(0.0) (2.9) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

INR increased 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Investigations - Other,

specify

2 0 0 0 0

2 1 0 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (3.0) (1.5) (0.0) (0.0) (0.0)

Lipase increased 0 0 0 1 0 0 0 0 0 0

(0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Lymphocyte count

decreased

0 3 11 11 0

3 2 10 11 0

(0.0) (4.3) (15.7) (15.7) (0.0) (4.5) (3.0) (14.9) (16.4) (0.0)

Lymphocyte count

increased

0 0 1 0 0

0 1 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Neutrophil count

decreased

10 7 14 1 0

9 14 10 1 0

(14.3) (10.0) (20.0) (1.4) (0.0) (13.4) (20.9) (14.9) (1.5) (0.0)

Platelet count decreased 39 3 1 0 0 38 6 0 0 0

(55.7) (4.3) (1.4) (0.0) (0.0) (56.7) (9.0) (0.0) (0.0) (0.0)

Weight gain 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Weight loss 11 12 3 0 0 12 12 6 0 0

(15.7) (17.1) (4.3) (0.0) (0.0) (17.9) (17.9) (9.0) (0.0) (0.0)

White blood cell

decreased

13 21 16 4 0

5 29 21 3 0

(18.6) (30.0) (22.9) (5.7) (0.0) (7.5) (43.3) (31.3) (4.5) (0.0)

METABOLISM AND

NUTRITION DISORDERS

18 23 12 1 0

11 19 20 0 0

(25.7) (32.9) (17.1) (1.4) (0.0) (16.4) (28.4) (29.9) (0.0) (0.0)

Acidosis 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Anorexia 12 12 5 0 0 7 18 5 0 0

(17.1) (17.1) (7.1) (0.0) (0.0) (10.4) (26.9) (7.5) (0.0) (0.0)

Dehydration 1 12 5 0 0 1 11 11 0 0

(1.4) (17.1) (7.1) (0.0) (0.0) (1.5) (16.4) (16.4) (0.0) (0.0)

Glucose intolerance 1 0 0 0 0 0 1 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Hypercalcemia 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Hyperglycemia 11 7 5 1 0 9 10 2 0 0


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

(15.7) (10.0) (7.1) (1.4) (0.0) (13.4) (14.9) (3.0) (0.0) (0.0)

Hyperkalemia 2 2 1 0 0 2 3 0 0 0

(2.9) (2.9) (1.4) (0.0) (0.0) (3.0) (4.5) (0.0) (0.0) (0.0)

Hypermagnesemia 0 0 1 0 0 0 0 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Hypernatremia 4 0 1 0 0 3 0 0 0 0

(5.7) (0.0) (1.4) (0.0) (0.0) (4.5) (0.0) (0.0) (0.0) (0.0)

Hyperuricemia 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Hypoalbuminemia 10 5 0 0 0 8 6 1 0 0

(14.3) (7.1) (0.0) (0.0) (0.0) (11.9) (9.0) (1.5) (0.0) (0.0)

Hypocalcemia 6 5 1 0 0 8 4 1 0 0

(8.6) (7.1) (1.4) (0.0) (0.0) (11.9) (6.0) (1.5) (0.0) (0.0)

Hypoglycemia 3 0 0 0 0 1 0 0 0 0

(4.3) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Hypokalemia 7 0 1 0 0 7 3 3 0 0

(10.0) (0.0) (1.4) (0.0) (0.0) (10.4) (4.5) (4.5) (0.0) (0.0)

Hypomagnesemia 3 0 0 0 0 8 0 0 0 0

(4.3) (0.0) (0.0) (0.0) (0.0) (11.9) (0.0) (0.0) (0.0) (0.0)

Hyponatremia 18 0 1 0 0 16 0 1 0 0

(25.7) (0.0) (1.4) (0.0) (0.0) (23.9) (0.0) (1.5) (0.0) (0.0)

Hypophosphatemia 0 1 1 0 0 1 2 1 0 0

(0.0) (1.4) (1.4) (0.0) (0.0) (1.5) (3.0) (1.5) (0.0) (0.0)


disorders - Other, specify

1 1 0 0 0

1 0 1 0 0

(1.4) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (1.5) (0.0) (0.0)

MUSCULOSKELETAL

AND CONNECTIVE

TISSUE DISORDERS

11 5 2 0 0

6 10 3 0 0

(15.7) (7.1) (2.9) (0.0) (0.0) (9.0) (14.9) (4.5) (0.0) (0.0)

Arthralgia 3 0 0 0 0 0 0 0 0 0

(4.3) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Arthritis 0 1 0 0 0 1 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Back pain 4 0 0 0 0 5 3 1 0 0

(5.7) (0.0) (0.0) (0.0) (0.0) (7.5) (4.5) (1.5) (0.0) (0.0)

Chest wall pain 1 1 0 0 0 0 0 0 0 0

(1.4) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Generalized muscle

weakness

1 1 2 0 0

1 4 2 0 0

(1.4) (1.4) (2.9) (0.0) (0.0) (1.5) (6.0) (3.0) (0.0) (0.0)


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

Muscle weakness left-

sided

0 1 0 0 0

0 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Musculoskeletal and

connective tissue disorder

- Other, specify

2 0 0 0 0

0 0 0 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Myalgia 3 1 0 0 0 1 1 0 0 0

(4.3) (1.4) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0) (0.0) (0.0)

Neck pain 0 1 0 0 0 0 2 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (3.0) (0.0) (0.0) (0.0)

Pain in extremity 2 0 0 0 0 0 2 0 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (0.0) (3.0) (0.0) (0.0) (0.0)

NERVOUS SYSTEM

DISORDERS

21 5 3 0 0

13 11 3 1 0

(30.0) (7.1) (4.3) (0.0) (0.0) (19.4) (16.4) (4.5) (1.5) (0.0)

Amnesia 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Cognitive disturbance 1 0 1 0 0 0 0 0 0 0

(1.4) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Dizziness 10 2 0 0 0 4 2 0 0 0

(14.3) (2.9) (0.0) (0.0) (0.0) (6.0) (3.0) (0.0) (0.0) (0.0)

Dysesthesia 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Dysgeusia 8 2 0 0 0 5 7 0 0 0

(11.4) (2.9) (0.0) (0.0) (0.0) (7.5) (10.4) (0.0) (0.0) (0.0)

Headache 4 0 1 0 0 4 2 1 0 0

(5.7) (0.0) (1.4) (0.0) (0.0) (6.0) (3.0) (1.5) (0.0) (0.0)

Lethargy 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Movements involuntary 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Nervous system disorders

- Other, specify

1 1 0 0 0

1 1 0 0 0

(1.4) (1.4) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0) (0.0) (0.0)

Paresthesia 1 0 0 0 0 1 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Peripheral motor

neuropathy

1 0 0 0 0

0 1 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Peripheral sensory

neuropathy

9 0 0 0 0

10 2 0 0 0


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

(12.9) (0.0) (0.0) (0.0) (0.0) (14.9) (3.0) (0.0) (0.0) (0.0)

Presyncope 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Recurrent laryngeal nerve

palsy

0 0 0 0 0

0 0 1 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Seizure 0 1 0 0 0 0 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Stroke 0 1 0 0 0 0 0 0 1 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0)

Syncope 0 0 1 0 0 0 0 1 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Tremor 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Vagus nerve disorder 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

PSYCHIATRIC

DISORDERS

16 7 2 0 0

13 8 1 0 0

(22.9) (10.0) (2.9) (0.0) (0.0) (19.4) (11.9) (1.5) (0.0) (0.0)

Agitation 1 0 0 0 0 1 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Anxiety 5 6 0 0 0 7 3 1 0 0

(7.1) (8.6) (0.0) (0.0) (0.0) (10.4) (4.5) (1.5) (0.0) (0.0)

Confusion 2 0 0 0 0 0 0 0 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Delirium 0 0 1 0 0 1 0 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Depression 4 1 0 0 0 3 2 0 0 0

(5.7) (1.4) (0.0) (0.0) (0.0) (4.5) (3.0) (0.0) (0.0) (0.0)

Insomnia 11 0 0 0 0 8 5 0 0 0

(15.7) (0.0) (0.0) (0.0) (0.0) (11.9) (7.5) (0.0) (0.0) (0.0)

Mania 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Psychiatric disorders -

Other, specify

0 0 1 0 0

0 0 0 0 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

RENAL AND URINARY

DISORDERS

4 2 1 1 0

1 1 1 0 0

(5.7) (2.9) (1.4) (1.4) (0.0) (1.5) (1.5) (1.5) (0.0) (0.0)

Acute kidney injury 1 1 0 1 0 0 1 0 0 0

(1.4) (1.4) (0.0) (1.4) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Hematuria 0 2 0 0 0 0 0 1 0 0


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

(0.0) (2.9) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Proteinuria 0 1 1 0 0 0 0 0 0 0

(0.0) (1.4) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Renal calculi 0 1 0 0 0 0 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Urinary frequency 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Urinary incontinence 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Urinary tract obstruction 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Urinary tract pain 0 0 0 0 0 2 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (3.0) (0.0) (0.0) (0.0) (0.0)

Urine discoloration 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

REPRODUCTIVE

SYSTEM AND BREAST

DISORDERS

0 0 0 0 0

0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Erectile dysfunction 0 0 0 0 0 0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

RESPIRATORY,

THORACIC AND

MEDIASTINAL

DISORDERS

17 15 3 1 2

16 9 7 2 0

(24.3) (21.4) (4.3) (1.4) (2.9) (23.9) (13.4) (10.4) (3.0) (0.0)

Allergic rhinitis 3 1 0 0 0 2 1 0 0 0

(4.3) (1.4) (0.0) (0.0) (0.0) (3.0) (1.5) (0.0) (0.0) (0.0)

Aspiration 0 0 1 0 0 0 1 1 1 0

(0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (1.5) (1.5) (1.5) (0.0)

Atelectasis 2 0 0 0 0 1 1 1 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (1.5) (0.0) (0.0)

Bronchopleural fistula 0 0 0 0 1 0 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0)

Chylothorax 0 0 2 0 0 0 0 1 0 0

(0.0) (0.0) (2.9) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0)

Cough 10 3 0 0 0 11 2 0 0 0

(14.3) (4.3) (0.0) (0.0) (0.0) (16.4) (3.0) (0.0) (0.0) (0.0)

Dyspnea 15 5 0 0 0 8 3 2 0 0

(21.4) (7.1) (0.0) (0.0) (0.0) (11.9) (4.5) (3.0) (0.0) (0.0)

Epistaxis 4 2 0 0 0 3 2 0 0 0

(5.7) (2.9) (0.0) (0.0) (0.0) (4.5) (3.0) (0.0) (0.0) (0.0)


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

Hiccups 0 0 0 0 0 4 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (6.0) (0.0) (0.0) (0.0) (0.0)

Hoarseness 2 1 0 0 0 3 2 1 0 0

(2.9) (1.4) (0.0) (0.0) (0.0) (4.5) (3.0) (1.5) (0.0) (0.0)

Hypoxia 0 0 0 0 0 0 1 1 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0) (0.0)

Laryngeal inflammation 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Laryngopharyngeal

dysesthesia

1 0 0 0 0

0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Nasal congestion 1 0 0 0 0 1 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Pharyngolaryngeal pain 0 0 0 0 0 0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Pleural effusion 0 3 0 0 0 1 3 1 0 0

(0.0) (4.3) (0.0) (0.0) (0.0) (1.5) (4.5) (1.5) (0.0) (0.0)

Pleuritic pain 1 0 0 0 0 1 0 1 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (1.5) (0.0) (0.0)

Pneumonitis 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Pneumothorax 0 2 0 0 0 2 0 2 0 0

(0.0) (2.9) (0.0) (0.0) (0.0) (3.0) (0.0) (3.0) (0.0) (0.0)

Productive cough 1 0 0 0 0 5 3 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (7.5) (4.5) (0.0) (0.0) (0.0)

Pulmonary fibrosis 0 0 0 0 0 0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

Respiratory failure 0 0 0 2 1 0 0 0 0 0

(0.0) (0.0) (0.0) (2.9) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0)


mediastinal disorders -

Other, specify

2 4 1 0 0

0 0 2 1 0

(2.9) (5.7) (1.4) (0.0) (0.0) (0.0) (0.0) (3.0) (1.5) (0.0)

Sinus disorder 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Sleep apnea 0 1 0 0 0 0 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Sore throat 3 2 0 0 0 1 0 0 0 0

(4.3) (2.9) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Tracheal mucositis 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Voice alteration 0 1 0 0 0 1 0 1 0 0


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

(0.0) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (1.5) (0.0) (0.0)

Wheezing 1 0 0 0 0 1 1 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0) (0.0) (0.0)

SKIN AND

SUBCUTANEOUS

TISSUE DISORDERS

22 5 0 0 0

13 5 2 0 0

(31.4) (7.1) (0.0) (0.0) (0.0) (19.4) (7.5) (3.0) (0.0) (0.0)

Alopecia 6 1 0 0 0 4 2 0 0 0

(8.6) (1.4) (0.0) (0.0) (0.0) (6.0) (3.0) (0.0) (0.0) (0.0)

Bullous dermatitis 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Dry skin 3 0 0 0 0 2 0 0 0 0

(4.3) (0.0) (0.0) (0.0) (0.0) (3.0) (0.0) (0.0) (0.0) (0.0)

Erythema multiforme 0 0 0 0 0 2 0 1 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (3.0) (0.0) (1.5) (0.0) (0.0)

Hyperhidrosis 1 0 0 0 0 1 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Pain of skin 1 0 0 0 0 0 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Pruritus 1 2 0 0 0 4 0 0 0 0

(1.4) (2.9) (0.0) (0.0) (0.0) (6.0) (0.0) (0.0) (0.0) (0.0)

Rash acneiform 1 0 0 0 0 1 0 0 0 0

(1.4) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Rash maculo-papular 5 1 0 0 0 6 2 1 0 0

(7.1) (1.4) (0.0) (0.0) (0.0) (9.0) (3.0) (1.5) (0.0) (0.0)

Skin and subcutaneous

tissue disorders - Other,

specify

6 1 0 0 0

1 0 0 0 0

(8.6) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Skin hyperpigmentation 2 0 0 0 0 0 0 0 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Skin ulceration 0 0 0 0 0 0 1 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)

SURGICAL AND

MEDICAL PROCEDURES

0 1 0 0 0

0 0 1 1 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0)


procedures - Other,

specify

0 1 0 0 0

0 0 1 1 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0)

VASCULAR DISORDERS 1 7 6 2 0 3 10 5 1 0

(1.4) (10.0) (8.6) (2.9) (0.0) (4.5) (14.9) (7.5) (1.5) (0.0)


Table 8




RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

Flushing 1 1 0 0 0 1 0 0 0 0

(1.4) (1.4) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Hot flashes 0 0 0 0 0 1 0 0 0 0

(0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0) (0.0)

Hypertension 1 3 2 0 0 1 6 2 0 0

(1.4) (4.3) (2.9) (0.0) (0.0) (1.5) (9.0) (3.0) (0.0) (0.0)

Hypotension 0 3 3 2 0 1 7 2 0 0

(0.0) (4.3) (4.3) (2.9) (0.0) (1.5) (10.4) (3.0) (0.0) (0.0)

Superficial

thrombophlebitis

0 1 0 0 0

0 0 0 0 0

(0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)

Thromboembolic event 0 1 2 0 0 0 1 2 1 0

(0.0) (1.4) (2.9) (0.0) (0.0) (0.0) (1.5) (3.0) (1.5) (0.0)


Table 9



Definitely, Probably, or Possibly Related to Protocol Treatment

RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

Overall Highest Grade 3 22 26 16 3 0 16 35 14 2

(4.3) (31.4) (37.1) (22.9) (4.3) (0.0) (23.9) (52.2) (20.9) (3.0)

Blood and lymphatic system

disorders

24 9 7 1 0

23 15 2 0 0

(34.3) (12.9) (10.0) (1.4) (0.0) (34.3) (22.4) (3.0) (0.0) (0.0)

Cardiac disorders 2 3 3 0 0 5 1 1 1 0

(2.9) (4.3) (4.3) (0.0) (0.0) (7.5) (1.5) (1.5) (1.5) (0.0)

Ear and labyrinth disorders 2 0 0 0 0 2 1 0 0 0

(2.9) (0.0) (0.0) (0.0) (0.0) (3.0) (1.5) (0.0) (0.0) (0.0)

Gastrointestinal disorders 22 31 11 2 0 18 28 13 1 0

(31.4) (44.3) (15.7) (2.9) (0.0) (26.9) (41.8) (19.4) (1.5) (0.0)


administration site conditions

27 20 2 1 2

19 25 6 0 1

(38.6) (28.6) (2.9) (1.4) (2.9) (28.4) (37.3) (9.0) (0.0) (1.5)

Hepatobiliary disorders 0 0 0 1 0 0 0 0 0 0

(0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0)


Table 9



Definitely, Probably, or Possibly Related to Protocol Treatment

RT+Paclitaxel+



1 2 3 4 5 1 2 3 4 5

Infections and infestations 0 1 5 3 0 0 3 5 1 1

(0.0) (1.4) (7.1) (4.3) (0.0) (0.0) (4.5) (7.5) (1.5) (1.5)

Injury, poisoning and

procedural complications

9 0 0 0 0

10 0 1 1 0

(12.9) (0.0) (0.0) (0.0) (0.0) (14.9) (0.0) (1.5) (1.5) (0.0)

Investigations 8 22 21 12 0 6 24 25 12 0

(11.4) (31.4) (30.0) (17.1) (0.0) (9.0) (35.8) (37.3) (17.9) (0.0)


disorders

19 17 9 0 0

10 16 15 0 0

(27.1) (24.3) (12.9) (0.0) (0.0) (14.9) (23.9) (22.4) (0.0) (0.0)

Musculoskeletal and connective

tissue disorders

6 3 0 0 0

3 3 2 0 0

(8.6) (4.3) (0.0) (0.0) (0.0) (4.5) (4.5) (3.0) (0.0) (0.0)

Nervous system disorders 18 5 0 0 0 11 9 2 1 0

(25.7) (7.1) (0.0) (0.0) (0.0) (16.4) (13.4) (3.0) (1.5) (0.0)

Psychiatric disorders 4 2 2 0 0 7 5 0 0 0

(5.7) (2.9) (2.9) (0.0) (0.0) (10.4) (7.5) (0.0) (0.0) (0.0)

Renal and urinary disorders 0 0 0 1 0 0 1 0 0 0

(0.0) (0.0) (0.0) (1.4) (0.0) (0.0) (1.5) (0.0) (0.0) (0.0)



8 8 0 1 1

11 5 4 1 0

(11.4) (11.4) (0.0) (1.4) (1.4) (16.4) (7.5) (6.0) (1.5) (0.0)

Skin and subcutaneous tissue

disorders

17 4 0 0 0

12 4 1 0 0

(24.3) (5.7) (0.0) (0.0) (0.0) (17.9) (6.0) (1.5) (0.0) (0.0)


procedures

0 0 0 0 0

0 0 1 1 0

(0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (0.0) (1.5) (1.5) (0.0)

Vascular disorders 1 4 3 1 0 2 5 4 0 0

(1.4) (5.7) (4.3) (1.4) (0.0) (3.0) (7.5) (6.0) (0.0) (0.0)



Table 10

Grade 5 Adverse Events for RTOG 1010 Patients - Data as of 10/31/2014


Assigned

Treatment

System Organ Class

Term

Relationship

to Treatment

Days from

Start of

Treatment

Days from

End of

Treatment

RT+Paclitaxel+

Carboplatin+

Trastuzumab



Bronchopleural fistula Definite 105 49


administration site

conditions

Death NOS Possible 35 0



Respiratory failure Unrelated 525 487


administration site

conditions

Sudden death NOS Probable 102 61

RT+Paclitaxel+

Carboplatin


administration site

conditions

Multi-organ failure Unlikely 104 67


administration site

conditions

Multi-organ failure Possible 143 106

Infections and

infestations

Sepsis Probable 78 40

Adverse events were graded with CTCAE version 4.

Health Outcomes Research

Table 11

Pretreatment PRO-QOL Compliance for All Eligible Patients with On-Study Data in

RTOG 1010 - Data as of 10/31/2014

RT+Paclitaxel

+Carboplatin+

Trastuzumab

(n=74)

RT+Paclitaxel

+Carboplatin

(n=74)

Total

(n=148)

n % n % n %

Consented to PRO-QOL collection 67 90.5 66 89.2 133 89.9

Did not consent to PRO-QOL collection 7 9.5 8 10.8 15 10.1

Functional Assessment of Cancer Therapy - Esophagus 67 66 133

Completed, prior to start of treatment 65 97.0 60 90.9 125 94.0

Completed, after start of treatment 1 1.5 2 3.0 3 2.3

Not completed, institution error 1 1.5 0 0.0 1 0.8


Table 11

Pretreatment PRO-QOL Compliance for All Eligible Patients with On-Study Data in

RTOG 1010 - Data as of 10/31/2014

RT+Paclitaxel

+Carboplatin+

Trastuzumab

(n=74)

RT+Paclitaxel

+Carboplatin

(n=74)

Total

(n=148)

n % n % n %

Not completed, patient refusal 0 0.0 1 1.5 1 0.8

Not completed, unknown reason 0 0.0 1 1.5 1 0.8

Not received 0 0.0 2 3.0 2 1.5

Health Utility Measurement EuroQOL 67 66 133

Completed, prior to start of treatment 52 77.6 47 71.2 99 74.4

Completed, after start of treatment 1 1.5 3 4.5 4 3.0

Not completed, institution error 0 0.0 1 1.5 1 0.8

Not completed, patient refusal 0 0.0 1 1.5 1 0.8

Not completed, unknown reason 1 1.5 0 0.0 1 0.8

Not received 13 19.4 14 21.2 27 20.3

PRO = patient-reported outcome; QOL = quality of life.

Translational Research

Table 12

Translational Research Consent and Specimen Submission for All Eligible Patients with On-

Study Data in RTOG 1010 - Data as of 10/31/2014

RT+Paclitaxel+

Carboplatin+

Trastuzumab

(n=74)

RT+Paclitaxel+

Carboplatin

(n=74)

Total

(n=148)

n % n % n %

Consented to tissue collection 69 93.2 66 89.2 135 91.2

Block(s) submitted only 31 44.9 34 51.5 65 48.1

Block(s) and unstained slides submitted 37 53.6 30 45.5 67 49.6

Consented to blood collection 65 87.8 66 89.2 131 88.5

Whole blood submitted 56 86.2 53 80.3 109 83.2

Plasma submitted 56 86.2 53 80.3 109 83.2

Consented to urine collection 66 89.2 65 87.8 131 88.5

Urine submitted 57 86.4 51 78.5 108 82.4

Submission is as of October 31, 2014.

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