Phase 2b Study of Cetuximab With Platinum-Based Chemo as First Line Treatment of Recurrent or Advanced NSCLC

• Sponsor: Accelerated Community Oncology Research Network (Other)
• Overall Status: Completed
• CT.gov ID: NCT00828841
• Collaborator: (none)
• Enrollment: 601
• Locations: 84
• Arms: 3
• Duration (Months): 44
• Patients Per Site: 7.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study is testing the investigational drug, cetuximab, in combination with different chemotherapy drugs for lung cancer. The aim of the study is to determine which of the drug combinations looks most promising and should be tested further. The study will also look at what side effects may occur.

Condition or Disease	Intervention/Treatment	Phase
Non-Small Cell Lung Cancer	Drug: Cetuximab; Drug: Paclitaxel; Drug: Carboplatin; Drug: Gemcitabine; Drug: Cisplatin	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 601 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Multi-Center Randomized Phase 2b Study of Cetuximab (Erbitux) in Combination With Platinum-Based Chemotherapy as First Line Treatment of Patients With Recurrent or Advanced Non-Small Cell Lung Cancer (NSCLC)
• Study Start Date: Dec 1, 2008
• Actual Primary Completion Date: Jul 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Paclitaxel, Carboplatin, Cetuximab (Arm A) Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.	Drug: Cetuximab; Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.; Other Names: Erbitux ; Drug: Paclitaxel; Paclitaxel 200 mg/m2 Day 1 every 21 days; Other Names: Taxol ; Drug: Carboplatin; Carboplatin AUC 6 Day 1 every 21 days; Other Names: Paraplatin
Active Comparator: Platinum, Gemcitabine, Cetuximab (Arm B) Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.	Drug: Cetuximab; Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.; Other Names: Erbitux ; Drug: Carboplatin; Carboplatin AUC 6 Day 1 every 21 days; Other Names: Paraplatin ; Drug: Gemcitabine; Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days; Other Names: Gemzar ; Drug: Cisplatin; Cisplatin 75 mg/m2 Day I every 21 days; Other Names: Platinol
Active Comparator: Platinum, Pemetrexed, Cetuximab (Arm C) Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.	Drug: Cetuximab; Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.; Other Names: Erbitux ; Drug: Carboplatin; Carboplatin AUC 6 Day 1 every 21 days; Other Names: Paraplatin ; Drug: Cisplatin; Cisplatin 75 mg/m2 Day I every 21 days; Other Names: Platinol

Outcome Measures

Primary Outcome Measures

1. Overall Survival by Treatment Arm [Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.]

Secondary Outcome Measures

1. 1-year Survival by Treatment Arm [Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.]

2. Overall Survival by Histology [Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Written informed consent before study-related activities

• Histologically or cytologically confirmed Stage IIIb with cytologically documented malignant pleural or pericardial effusion, Stage IV, or recurrent non-smal cell lung cancer (NSCLC) after resection or radiation for earlier stage disease

• Measurable or evaluable disease (per modified Response Evaluation Criteria in Solid Tumors [RECIST] guidelines)

• Male or female ≥ 18 years of age

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1

• White blood count ≥ 3 x 10(9)/L with neutrophils ≥ 1.5 x 10(9)/L, platelet count ≥ 100 x 10(9)/L, and hemoglobin ≥ 9.5 g/dL

• Total bilirubin ≤ 1.5 x upper limit of normal (ULN)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver mets

• Serum creatinine ≤ 1.25 x ULN

• Recovery from prior surgery or radiation to Grade 1 or better toxicity

• Women of childbearing potential (WOCBP) and fertile men with partners of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 wks after the study in such a manner that the risk of pregnancy is minimized

• WOCBP must have a negative serum or urine pregnancy test within 72 hrs prior to the start of study medication or in accordance with local regulations, whichever is of shorter duration

Exclusion Criteria:

• WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 4 weeks after the study

• Women who are pregnant or breastfeeding

• Women with a positive pregnancy test during screening or prior to study drug administration

• Sexually active fertile men not using effective birth control if their partners are women of child-bearing potential

• Prior chemo for advanced NSCLC; neoadjuvant or post-operative adjuvant chemo is allowed if completed at least 12 months before study entry

• Previous exposure to epidermal growth factor receptor (EGFR)-targeted therapy. Prior treatment with monoclonal antibodies targeting receptors other than the EGFR, such as bevacizumab, is allowed if completed > 30 days prior to randomization

• Treatment with any investigational agent(s) within 4 weeks prior to study entry

• Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, biologic or targeted therapy) other than protocol therapy

• Carcinoid, atypical carcinoid or small cell lung cancer

• Symptomatic or uncontrolled mets in the central nervous system

• Prior invasive malignancy requiring ongoing therapy within the past year

• Active infection (infection requiring intravenous [IV] antibiotics), including active tuberculosis, known and declared HIV

• Myocardial infarction within 6 months prior to study entry, uncontrolled congestive heart failure; or any current Grade 3 or 4 cardiovascular disorder despite treatment

• Known allergic/hypersensitivity reaction to any of the components of study treatments

• Peripheral neuropathy ≥ Grade 2, as assessed by Common Terminology Criteria for Adverse Events, version 3.0

• History of significant neurologic or psychiatric disorders including but not limited to dementia, seizures, and bipolar disorder

• Medical or psychological condition that would not permit the patient to complete the study or sign informed consent

• Known drug abuse

Patients of all races and ethnic groups are eligible for this trial.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Anniston	Alabama	United States
2		Jonesboro	Arkansas	United States
3		Anaheim	California	United States
4		Azusa	California	United States
5		Burbank	California	United States
6		Campbell	California	United States
7		Greenbrae	California	United States
8		Hawthorne	California	United States
9		Mission Hills	California	United States
10		Orange	California	United States
11		Oxnard	California	United States
12		St. Helena	California	United States
13		Fort Collins	Colorado	United States
14		Norwich	Connecticut	United States
15		Torrington	Connecticut	United States
16		Trumbull	Connecticut	United States
17		Fort Lauderdale	Florida	United States
18		Lake Worth	Florida	United States
19		Orange City	Florida	United States
20		Pembroke Pines	Florida	United States
21		St. Petersburg	Florida	United States
22		Titusville	Florida	United States
23		Weston	Florida	United States
24		Augusta	Georgia	United States
25		Columbus	Georgia	United States
26		Lawrenceville	Georgia	United States
27		Marietta	Georgia	United States
28		Valdosta	Georgia	United States
29		Elmhurst	Illinois	United States
30		Harvey	Illinois	United States
31		Joliet	Illinois	United States
32		Quincy	Illinois	United States
33		Skokie	Illinois	United States
34		South Bend	Indiana	United States
35	Family Medicine of Vincennes	Vincennes	Indiana	United States
36		Arnes	Iowa	United States
37		Bettendorf	Iowa	United States
38		Mason City	Iowa	United States
39		Waterloo	Iowa	United States
40		Hazard	Kentucky	United States
41		Louisville	Kentucky	United States
42		Lafayette	Louisiana	United States
43		Shreveport	Louisiana	United States
44		Baltimore	Maryland	United States
45		Towson	Maryland	United States
46		Springfield	Massachusetts	United States
47		Worchester	Massachusetts	United States
48		Jefferson City	Missouri	United States
49		St. Joseph	Missouri	United States
50		St. Louis	Missouri	United States
51		Billings	Montana	United States
52		Grand Island	Nebraska	United States
53		Omaha	Nebraska	United States
54		Portsmouth	New Hampshire	United States
55		Bellville	New Jersey	United States
56		Cherry Hill	New Jersey	United States
57		Elizabeth	New Jersey	United States
58		Hackensack	New Jersey	United States
59		Bronx	New York	United States
60		East Setauket	New York	United States
61		Fresh Meadows	New York	United States
62		Fayetteville	North Carolina	United States
63		Gastonia	North Carolina	United States
64		Goldsboro	North Carolina	United States
65		Columbus	Ohio	United States
66		Dayton	Ohio	United States
67		Middletown	Ohio	United States
68		Sandusky	Ohio	United States
69		Bend	Oregon	United States
70		Bethlehem	Pennsylvania	United States
71		Reading	Pennsylvania	United States
72		Sumter	South Carolina	United States
73		Sioux Falls	South Dakota	United States
74		Bristol	Tennessee	United States
75		Chattanooga	Tennessee	United States
76		Memphis	Tennessee	United States
77		Beaumont	Texas	United States
78		Corpus Christi	Texas	United States
79		Lubbock	Texas	United States
80		Bennington	Vermont	United States
81		Kirkland	Washington	United States
82		Tacoma	Washington	United States
83		Huntington	West Virginia	United States
84		Wauwatosa	Wisconsin	United States

Sponsors and Collaborators

• Accelerated Community Oncology Research Network

Investigators

• Study Chair: Lee Schwartzberg, MD, FACP, Accelerated Community Oncology Research Network

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Accelerated Community Oncology Research Network
• ClinicalTrials.gov Identifier: NCT00828841
• Other Study ID Numbers: AC01L08
• First Posted: Jan 26, 2009
• Last Update Posted: Nov 6, 2013
• Last Verified: Oct 1, 2013

• Additional relevant MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Gemcitabine; Paclitaxel; Carboplatin; Cetuximab

Study Results

Participant Flow

Recruitment Details	The study was open to enrollment at 118 oncology clinics from November 2008 to May 2011.
Pre-assignment Detail	Consent was obtained from all subjects. Subjects were stratified by histology (non-squamous vs. squamous), followed by disease stage (IIIb vs. IV). Subjects in the non-squamous stratum were randomized to 1 of 3 treatment arms (Arm A, B, or C); subjects in the squamous stratum were randomized to only 1 of 2 of these treatment arms (Arm A or B).

Arm/Group Title	Paclitaxel, Carboplatin, Cetuximab (Arm A)	Platinum, Gemcitabine, Cetuximab (Arm B)	Platinum, Pemetrexed, Cetuximab (Arm C)
Arm/Group Description	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm. Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Period Title: Overall Study
STARTED	235	236	130
COMPLETED	231	232	126
NOT COMPLETED	4	4	4

Baseline Characteristics

Arm/Group Title	Paclitaxel, Carboplatin, Cetuximab (Arm A)	Platinum, Gemcitabine, Cetuximab (Arm B)	Platinum, Pemetrexed, Cetuximab (Arm C)	Total
Arm/Group Description	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm. Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	Total of all reporting groups
Overall Participants	235	236	130	601
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.3 (8.9)	64.9 (9.5)	65.6 (9.4)	65.2 (9.2)
Sex: Female, Male (Count of Participants)
Female	97 41.3%	90 38.1%	64 49.2%	251 41.8%
Male	138 58.7%	146 61.9%	66 50.8%	350 58.2%
Region of Enrollment (participants) [Number]
United States	235 100%	236 100%	130 100%	601 100%

Outcome Measures

1. Primary Outcome

Title	Overall Survival by Treatment Arm
Time Frame	Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Outcome Measure Data

Analysis Population Description

Two subjects in Arm A were censored due to negative event intervals.

Arm/Group Title	Paclitaxel, Carboplatin, Cetuximab (Arm A)	Platinum, Gemcitabine, Cetuximab (Arm B)	Platinum, Pemetrexed, Cetuximab (Arm C)
Arm/Group Description	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm. Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Measure Participants	233	236	130
Median (95% Confidence Interval) [Months]	9.5	8.3	10.6

2. Secondary Outcome

Title	1-year Survival by Treatment Arm
Time Frame	Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Paclitaxel, Carboplatin, Cetuximab (Arm A)	Platinum, Gemcitabine, Cetuximab (Arm B)	Platinum, Pemetrexed, Cetuximab (Arm C)
Arm/Group Description	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.	Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm. Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
Measure Participants	233	236	130
Number (95% Confidence Interval) [percentage of participants]	39.7 16.9%	37.2 15.8%	47.3 36.4%

3. Secondary Outcome

Title	Overall Survival by Histology
Time Frame	Survival was measured from the date of randomization to date of death due to any cause, assessed up to 36 months. Subjects who were alive at the date of last contact were censored at the date of last contact.

Outcome Measure Data

Analysis Population Description

Subjects were stratified by histology prior to randomization to a treatment arm.

Arm/Group Title	Squamous Cell Histology	Non-squamous Cell Histology
Arm/Group Description	Subjects who were identified as having squamous cell histology, prior to randomization to a treatment arm.	Subjects who were identified as having non-squamous cell histology, prior to randomization to a treatment arm.
Measure Participants	200	399
Median (95% Confidence Interval) [Months]	8.7	9.9

Adverse Events

Time Frame	Adverse events collection began at the time the patient signed the informed consent and continued throughout the study until 30 days after the last dose.
Adverse Event Reporting Description	Systematic Assessment - subjects were assessed for adverse events by a member of the research team every 1-2 weeks.
Arm/Group Title	Paclitaxel, Carboplatin, Cetuximab (Arm A)		Platinum, Gemcitabine, Cetuximab (Arm B)		Platinum, Pemetrexed, Cetuximab (Arm C)
Arm/Group Description	Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.		Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.		Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm. Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days Carboplatin : Carboplatin AUC 6 Day 1 every 21 days Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks.
All Cause Mortality
	Paclitaxel, Carboplatin, Cetuximab (Arm A)		Platinum, Gemcitabine, Cetuximab (Arm B)		Platinum, Pemetrexed, Cetuximab (Arm C)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Paclitaxel, Carboplatin, Cetuximab (Arm A)		Platinum, Gemcitabine, Cetuximab (Arm B)		Platinum, Pemetrexed, Cetuximab (Arm C)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	109/235 (46.4%)		128/236 (54.2%)		68/130 (52.3%)
Blood and lymphatic system disorders
Anemia	2/235 (0.9%)		19/236 (8.1%)		6/130 (4.6%)
Febrile Neutropenia	6/235 (2.6%)		4/236 (1.7%)		2/130 (1.5%)
Leukocytosis	0/235 (0%)		0/236 (0%)		2/130 (1.5%)
Leukopenia	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Neutropenia	6/235 (2.6%)		4/236 (1.7%)		1/130 (0.8%)
Pancytopenia	1/235 (0.4%)		5/236 (2.1%)		1/130 (0.8%)
Thrombocytopenia	3/235 (1.3%)		15/236 (6.4%)		3/130 (2.3%)
Cardiac disorders
Acute Myocardial Infarction	0/235 (0%)		3/236 (1.3%)		0/130 (0%)
Atrial Fibrillation	3/235 (1.3%)		4/236 (1.7%)		0/130 (0%)
Atrial Flutter	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Cardiac Arrest	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Cardiac Failure Congestive	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Cardiac Tamponade	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Cardio-Respiratory Arrest	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Left Ventricular Dysfunction	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Myocardial Infarction	3/235 (1.3%)		3/236 (1.3%)		0/130 (0%)
Myocardial Ischemia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Pericardial Effusion	0/235 (0%)		3/236 (1.3%)		2/130 (1.5%)
Restrictive Cardiomyopathy	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Supraventricular Tachycardia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Tachycardia	3/235 (1.3%)		0/236 (0%)		1/130 (0.8%)
Ventricular Dysfunction	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Ear and labyrinth disorders
Vertigo	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Eye disorders
Ulcerative Keratitis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Gastrointestinal disorders
Abdominal Discomfort	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Abdominal Pain	2/235 (0.9%)		5/236 (2.1%)		1/130 (0.8%)
Abdominal Pain Upper	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Colitis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Constipation	0/235 (0%)		1/236 (0.4%)		2/130 (1.5%)
Diarrhea	4/235 (1.7%)		2/236 (0.8%)		1/130 (0.8%)
Dysphagia	1/235 (0.4%)		2/236 (0.8%)		0/130 (0%)
Enterocutaneous Fistula	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Esophageal Pain	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Gastric Ulcer Hemorrhage	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Gastric Volvulus	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Gastritis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Gastrointestinal Hemorrhage	2/235 (0.9%)		3/236 (1.3%)		2/130 (1.5%)
Intestinal Obstruction	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Nausea	2/235 (0.9%)		3/236 (1.3%)		4/130 (3.1%)
Rectal Hemorrhage	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Upper Gastrointestinal Hemorrhage	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Volvulus	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Vomiting	3/235 (1.3%)		3/236 (1.3%)		3/130 (2.3%)
General disorders
Adverse Reation	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Asthenia	3/235 (1.3%)		2/236 (0.8%)		1/130 (0.8%)
Chest Pain	6/235 (2.6%)		5/236 (2.1%)		1/130 (0.8%)
Chills	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Death	5/235 (2.1%)		3/236 (1.3%)		2/130 (1.5%)
Disease Progression	5/235 (2.1%)		7/236 (3%)		6/130 (4.6%)
Fatigue	0/235 (0%)		3/236 (1.3%)		1/130 (0.8%)
General Physical Health Deterioration	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Generalized Edema	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Multi-Organ Failure	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Pain	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Peripheral Edema	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Pyrexia	3/235 (1.3%)		2/236 (0.8%)		1/130 (0.8%)
Spinal Pain	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Ulcer Hemorrhage	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Hepatobiliary disorders
Cholecystitis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Cholelithiasis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Immune system disorders
Anaphylactic Reaction	2/235 (0.9%)		6/236 (2.5%)		0/130 (0%)
Cytokine Release Syndrome	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Drug Hypersensitivity	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Hypersensitivity	4/235 (1.7%)		2/236 (0.8%)		2/130 (1.5%)
Lung Infection	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Infections and infestations
Bacteremia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Bronchitis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Bronchopneumonia	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Catheter Site Infection	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Cellulitis	0/235 (0%)		2/236 (0.8%)		2/130 (1.5%)
Clostridial Infection	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Clostridium Difficile Colitis	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Diverticulitis	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Fungemia	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Gastroenteritis	0/235 (0%)		0/236 (0%)		2/130 (1.5%)
Gastroenteritis Viral	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Infection	3/235 (1.3%)		0/236 (0%)		0/130 (0%)
Infectious Pleural Effusion	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Neutropenic Sepsis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Pneumonia	15/235 (6.4%)		9/236 (3.8%)		2/130 (1.5%)
Respiratory Tract Infection	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Sepsis	3/235 (1.3%)		0/236 (0%)		4/130 (3.1%)
Staphylococcal Infection	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Urinart Tract Infection	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Urosepsis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Injury, poisoning and procedural complications
Accidental Exposure	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Ankle Fracture	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Humerus Fracture	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Infusion Related Reaction	8/235 (3.4%)		2/236 (0.8%)		3/130 (2.3%)
Medication Error	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Pneumothorax Traumatic	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Radiation Pneumonitis	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Recall Phenomenon	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Splenic Hematoma	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Subdural Hematoma	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Thoracic Vertebral Fracture	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Toxicity to Various Agents	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Investigations
Blood Creatinine Increased	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Blood/Bone Marrow Hemoglobin	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Eastern Cooperative Oncology Group Performance Status	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Ejection Fraction Decreased	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hemoglobin	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Lipase Increased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Neutrophil Count	1/235 (0.4%)		1/236 (0.4%)		2/130 (1.5%)
Neutrophil Count Decreased	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Platelet Count Decreased	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Transaminases Increased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Troponin Increased	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
White Blood Cell Count	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
White Blood Cell Increased	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Metabolism and nutrition disorders
Decreased Appetite	2/235 (0.9%)		2/236 (0.8%)		1/130 (0.8%)
Dehydration	9/235 (3.8%)		8/236 (3.4%)		7/130 (5.4%)
Failure To Thrive	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Hypercalcemia	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Hyperglycemia	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Hypocalcemia	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Hypoglycemia	4/235 (1.7%)		0/236 (0%)		1/130 (0.8%)
Hypokalemia	3/235 (1.3%)		0/236 (0%)		0/130 (0%)
Hypomagnesemia	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Hyponatremia	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Musculoskeletal and connective tissue disorders
Arthralgia	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Back Pain	0/235 (0%)		2/236 (0.8%)		3/130 (2.3%)
Muscular Weakness	1/235 (0.4%)		1/236 (0.4%)		2/130 (1.5%)
Musculoskeletal Chest Pain	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Myalgia	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Pain In Extremity	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Large Cell Carcinoma Of The Respiratory Tract	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Metastases To Bone	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Metastasis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Neoplasm Malignant	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Non-Small Cell Lung Cancer Metastatic	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Pericardial Effusion Malignant	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Tumor Embolism	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Nervous system disorders
Brain Edema	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Central Nervous System Hemorrhage	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Central Pain Syndrome	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Cerebellar Infarction	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Cerebral Ischemia	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Cerebrovascular Accident	3/235 (1.3%)		3/236 (1.3%)		1/130 (0.8%)
Convulsion	2/235 (0.9%)		0/236 (0%)		1/130 (0.8%)
Dizziness	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Grand Mal Convulsion	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hemiparesis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Peripheral Sensory Neuropathy	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Spinal Cord Compression	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Syncope	2/235 (0.9%)		3/236 (1.3%)		3/130 (2.3%)
Transient Ischemic Attack	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Psychiatric disorders
Confusional State	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Depression	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Mental Status Changes	1/235 (0.4%)		3/236 (1.3%)		0/130 (0%)
Renal and urinary disorders
Dysuria	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hematuria	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Renal Failure	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Renal Failure Acute	3/235 (1.3%)		2/236 (0.8%)		1/130 (0.8%)
Urinary Retention	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Chronic Obstructive Pulmonary Disease	4/235 (1.7%)		2/236 (0.8%)		1/130 (0.8%)
Cough	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Dyspnea	5/235 (2.1%)		10/236 (4.2%)		6/130 (4.6%)
Dyspnea Exertional	2/235 (0.9%)		1/236 (0.4%)		0/130 (0%)
Hemoptysis	1/235 (0.4%)		3/236 (1.3%)		0/130 (0%)
Hypoxia	4/235 (1.7%)		1/236 (0.4%)		1/130 (0.8%)
Lung Infiltration	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Pleural Effusion	4/235 (1.7%)		9/236 (3.8%)		5/130 (3.8%)
Pleuritic Pain	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Pneumomediastinum	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Pneumonitis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Pneumothorax	5/235 (2.1%)		4/236 (1.7%)		0/130 (0%)
Pulmonary Embolism	10/235 (4.3%)		14/236 (5.9%)		3/130 (2.3%)
Pulmonary Hemorrhage	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Respiratory Depression	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Respiratory Failure	5/235 (2.1%)		1/236 (0.4%)		2/130 (1.5%)
Skin and subcutaneous tissue disorders
Subcutaneous Emphysema	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Surgical and medical procedures
Leg Amputation	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Vascular disorders
Arterial Thrombosis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Deep Vein Thrombosis	4/235 (1.7%)		9/236 (3.8%)		1/130 (0.8%)
Hypotension	2/235 (0.9%)		5/236 (2.1%)		2/130 (1.5%)
Superior Vena Cava Syndrome	1/235 (0.4%)		0/236 (0%)		2/130 (1.5%)
Thrombophlebitis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Thrombophlebitis Superficial	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Thrombosis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Vasculitis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Venous Valve Ruptured	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Other (Not Including Serious) Adverse Events
	Paclitaxel, Carboplatin, Cetuximab (Arm A)		Platinum, Gemcitabine, Cetuximab (Arm B)		Platinum, Pemetrexed, Cetuximab (Arm C)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	221/235 (94%)		215/236 (91.1%)		119/130 (91.5%)
Blood and lymphatic system disorders
Anemia	83/235 (35.3%)		105/236 (44.5%)		52/130 (40%)
Bone Marrow Failure	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Febrile Neutropenia	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Hemorrhage Diathesis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Iron Deficiency Anemia	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Leukocytosis	3/235 (1.3%)		1/236 (0.4%)		1/130 (0.8%)
Leukopenia	20/235 (8.5%)		20/236 (8.5%)		13/130 (10%)
Lymphadenopathy	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Lymphatic Disorder	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Lymphopenia	19/235 (8.1%)		18/236 (7.6%)		20/130 (15.4%)
Neutropenia	79/235 (33.6%)		91/236 (38.6%)		42/130 (32.3%)
Pancytopenia	2/235 (0.9%)		10/236 (4.2%)		3/130 (2.3%)
Thrombocytopenia	61/235 (26%)		122/236 (51.7%)		49/130 (37.7%)
Thrombocytosis	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
White Blood Cell Disorder	3/235 (1.3%)		4/236 (1.7%)		0/130 (0%)
Cardiac disorders
Angina Pectoris	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Arrhythmia	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Atrial Fibrillation	1/235 (0.4%)		4/236 (1.7%)		0/130 (0%)
Cardiac Valve Disease	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Left Ventricular Dysfunction	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Myocardial Infarction	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Palpitations	2/235 (0.9%)		2/236 (0.8%)		4/130 (3.1%)
Pericardial Effusion	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Sinus Tachycardia	3/235 (1.3%)		3/236 (1.3%)		0/130 (0%)
Tachycardia	9/235 (3.8%)		11/236 (4.7%)		3/130 (2.3%)
Ventricular Arrhythmia	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Congenital, familial and genetic disorders
Trichomegaly	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Ear and labyrinth disorders
Cerumen Impaction	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Deafness	3/235 (1.3%)		1/236 (0.4%)		0/130 (0%)
Ear Discomfort	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Ear Disorder	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Ear Pain	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Hyperacusis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Hypoacusis	2/235 (0.9%)		2/236 (0.8%)		0/130 (0%)
Inner Ear Disorder	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Middle Ear Effusion	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Tinnitus	4/235 (1.7%)		6/236 (2.5%)		2/130 (1.5%)
Vertigo	3/235 (1.3%)		4/236 (1.7%)		1/130 (0.8%)
Endocrine disorders
Adrenal Insufficiency	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Adrenal Mass	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Cushingoid	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Hypothyroidism	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Eye disorders
Blepharitis	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Blepharospasm	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Blindness	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Cataract	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Conjunctival Hemorrhage	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Conjunctivitis	4/235 (1.7%)		3/236 (1.3%)		5/130 (3.8%)
Dark Circles Under Eyes	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Diplopia	1/235 (0.4%)		3/236 (1.3%)		0/130 (0%)
Dry Eye	2/235 (0.9%)		2/236 (0.8%)		2/130 (1.5%)
Eye Inflammation	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Eye Irritation	1/235 (0.4%)		2/236 (0.8%)		2/130 (1.5%)
Eye Pruritus	0/235 (0%)		0/236 (0%)		2/130 (1.5%)
Eye Ptosis	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Eye Swelling	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Keratitis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Lacrimation Increased	3/235 (1.3%)		8/236 (3.4%)		8/130 (6.2%)
Optic Nerve Sheath Hemorrhage	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Periorbital Edema	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Photopsia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Retinal Vein Occlusion	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Vision Blurred	7/235 (3%)		7/236 (3%)		3/130 (2.3%)
Visual Impairment	3/235 (1.3%)		2/236 (0.8%)		3/130 (2.3%)
Xerophthalmia	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Gastrointestinal disorders
Abdominal Discomfort	0/235 (0%)		3/236 (1.3%)		2/130 (1.5%)
Abdominal Distension	0/235 (0%)		1/236 (0.4%)		2/130 (1.5%)
Abdominal Pain	19/235 (8.1%)		18/236 (7.6%)		7/130 (5.4%)
Abdominal Pain Lower	2/235 (0.9%)		5/236 (2.1%)		1/130 (0.8%)
Abdominal Pain Upper	7/235 (3%)		6/236 (2.5%)		4/130 (3.1%)
Anal Fissure	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Ascites	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Cheilitis	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Constipation	79/235 (33.6%)		75/236 (31.8%)		39/130 (30%)
Diarrhea	70/235 (29.8%)		47/236 (19.9%)		25/130 (19.2%)
Dry Mouth	4/235 (1.7%)		4/236 (1.7%)		3/130 (2.3%)
Duodenitis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Dyspepsia	14/235 (6%)		11/236 (4.7%)		8/130 (6.2%)
Dysphagia	7/235 (3%)		8/236 (3.4%)		11/130 (8.5%)
Esophagitis	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Fecal Incontinence	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Feces Discolored	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Feces Hard	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Flatulence	1/235 (0.4%)		5/236 (2.1%)		4/130 (3.1%)
Gastric Ulcer	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Gastritis	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Gastritis Hemorrhagic	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Gastroesophageal Reflux Disease	6/235 (2.6%)		5/236 (2.1%)		3/130 (2.3%)
Gastrointestinal Hemorrhage	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Gastrointestinal Pain	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Gingival Bleeding	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Gingival Pain	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Glossodynia	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Hematemesis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Hematochezia	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Hemorrhoidal Hemorrhage	0/235 (0%)		4/236 (1.7%)		0/130 (0%)
Hemorrhoids	2/235 (0.9%)		8/236 (3.4%)		4/130 (3.1%)
Inguinal Hernia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Intestinal Mass	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Lip Dry	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Lip Hemorrhage	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Mouth Hemorrhage	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Nausea	98/235 (41.7%)		84/236 (35.6%)		61/130 (46.9%)
Oral Discomfort	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Oral Mucosal Erythema	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Oral Pain	3/235 (1.3%)		2/236 (0.8%)		1/130 (0.8%)
Paresthesia Oral	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Perianal Erythema	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Proctalgia	2/235 (0.9%)		1/236 (0.4%)		1/130 (0.8%)
Rectal Hemorrhage	2/235 (0.9%)		4/236 (1.7%)		2/130 (1.5%)
Reflux Gastritis	1/235 (0.4%)		2/236 (0.8%)		1/130 (0.8%)
Retching	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Saliva Altered	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Salivary Hypersecretion	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Stomatitis	24/235 (10.2%)		20/236 (8.5%)		14/130 (10.8%)
Tongue Disorder	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Toothache	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Vomiting	41/235 (17.4%)		47/236 (19.9%)		27/130 (20.8%)
General disorders
Adverse Drug Reaction	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Asthenia	24/235 (10.2%)		13/236 (5.5%)		9/130 (6.9%)
Catheter Site Discharge	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Catheter Site Erythema	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Catheter Site Pain	2/235 (0.9%)		3/236 (1.3%)		1/130 (0.8%)
Chest Discomfort	3/235 (1.3%)		3/236 (1.3%)		1/130 (0.8%)
Chest Pain	13/235 (5.5%)		18/236 (7.6%)		10/130 (7.7%)
Chills	9/235 (3.8%)		14/236 (5.9%)		4/130 (3.1%)
Cyst	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Device Infusion Issue	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Device Malfunction	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Device Occlusion	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Disease Progression	1/235 (0.4%)		0/236 (0%)		2/130 (1.5%)
Drug Hypersensitivity	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Early Satiety	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Edema	4/235 (1.7%)		2/236 (0.8%)		4/130 (3.1%)
Effusion	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Extravasation	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Face Edema	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Fatigue	131/235 (55.7%)		131/236 (55.5%)		76/130 (58.5%)
Feeling Hot	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Feeling Jittery	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Gait Disturbance	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
General Physical Health Deterioration	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
General Symptom	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hernia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hypersensitivity	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hypothermia	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Implant Site Scar	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Inflammatory Pain	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Influenza Like Illness	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Infusion Site Extravasation	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Injection Site Reaction	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Local Swelling	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Localized Edema	1/235 (0.4%)		3/236 (1.3%)		1/130 (0.8%)
Malaise	1/235 (0.4%)		1/236 (0.4%)		2/130 (1.5%)
Mass	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Mucosal Inflammation	25/235 (10.6%)		12/236 (5.1%)		21/130 (16.2%)
Myalgia	2/235 (0.9%)		0/236 (0%)		1/130 (0.8%)
Non-Cardiac Chest Pain	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Pain	23/235 (9.8%)		16/236 (6.8%)		5/130 (3.8%)
Performance Status Decreased	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Peripheral Edema	26/235 (11.1%)		34/236 (14.4%)		12/130 (9.2%)
Pyrexia	23/235 (9.8%)		23/236 (9.7%)		10/130 (7.7%)
Sensation of Pressure	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Soft Tissue Inflammation	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Swelling	0/235 (0%)		0/236 (0%)		2/130 (1.5%)
Temperature Intolerance	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Tenderness	2/235 (0.9%)		2/236 (0.8%)		0/130 (0%)
Thirst	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Xerosis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Hepatobiliary disorders
Hepatic Function Abnormal	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hyperbiliubinemia	2/235 (0.9%)		2/236 (0.8%)		0/130 (0%)
Non-Alcoholic Steatohepatitis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Immune system disorders
Anaphylactic Reaction	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Drug Hypersensitivity	6/235 (2.6%)		3/236 (1.3%)		1/130 (0.8%)
Hypersensitivity	10/235 (4.3%)		4/236 (1.7%)		2/130 (1.5%)
Infections and infestations
Abscess Neck	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Bacterial Sepsis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Bronchitis	1/235 (0.4%)		5/236 (2.1%)		2/130 (1.5%)
Candidiasis	3/235 (1.3%)		3/236 (1.3%)		6/130 (4.6%)
Carbuncle	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Catheter Site Infection	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Cellulitis	2/235 (0.9%)		3/236 (1.3%)		3/130 (2.3%)
Conjunctivitis Infective	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Cystitis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Device Related Infection	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Diverticulitis	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Ear Infection	0/235 (0%)		0/236 (0%)		2/130 (1.5%)
Esophageal Candidiasis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Eye Infection	0/235 (0%)		0/236 (0%)		2/130 (1.5%)
Folliculitis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Fungal Infection	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Fungal Skin Infection	2/235 (0.9%)		2/236 (0.8%)		1/130 (0.8%)
Furuncle	2/235 (0.9%)		0/236 (0%)		2/130 (1.5%)
Gastroenteritis	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Gastrointestinal Infection	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Herpes Zoster	2/235 (0.9%)		3/236 (1.3%)		0/130 (0%)
Hordeolum	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Infection	0/235 (0%)		3/236 (1.3%)		1/130 (0.8%)
Influenza	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Laryngitis	1/235 (0.4%)		1/236 (0.4%)		1/130 (0.8%)
Localized Infection	4/235 (1.7%)		6/236 (2.5%)		1/130 (0.8%)
Lower Respiratory Tract Infection	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Lung Infection	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Lyme Disease	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Mastoiditis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Nail Bed Infection	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Nail Bed Inflammation	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Nail Infection	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Nasopharyngitis	1/235 (0.4%)		4/236 (1.7%)		1/130 (0.8%)
Onychomycosis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Oral Candidiasis	4/235 (1.7%)		5/236 (2.1%)		3/130 (2.3%)
Oral Herpes	1/235 (0.4%)		0/236 (0%)		2/130 (1.5%)
Oral Infection	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Otitis Externa	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Otitis Media	2/235 (0.9%)		0/236 (0%)		1/130 (0.8%)
Paronychia	11/235 (4.7%)		3/236 (1.3%)		7/130 (5.4%)
Parotitis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Perineal Abscess	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Pharyngitis Bacterial	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Pneumonia	9/235 (3.8%)		3/236 (1.3%)		6/130 (4.6%)
Respiratory Tract Infection	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Rhinitis	2/235 (0.9%)		0/236 (0%)		1/130 (0.8%)
Scrotal Infection	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Sinusitis	3/235 (1.3%)		1/236 (0.4%)		0/130 (0%)
Skin Candida	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Skin Infection	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Staphylococcal Bacteremia	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Staphylococcal Infection	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Staphylococcal Sepsis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Subcutaneous Abscess	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Tinea Cruris	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Tinea Pedis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Tooth Infection	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Upper Aerodigestive Tract Infection	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Upper Respiratory Tract Infection	7/235 (3%)		6/236 (2.5%)		4/130 (3.1%)
Urinary Tract Infection	9/235 (3.8%)		9/236 (3.8%)		7/130 (5.4%)
Vaginal Infection	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Viral Infection	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Vulvitis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Vulvovaginal Mycotic Infection	2/235 (0.9%)		2/236 (0.8%)		0/130 (0%)
Injury, poisoning and procedural complications
Ankle Fracture	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Aortic Injury	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Arthropod Bite	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Chemical Injury	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Contusion	6/235 (2.6%)		4/236 (1.7%)		4/130 (3.1%)
Excoriation	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Fall	3/235 (1.3%)		1/236 (0.4%)		0/130 (0%)
Hip Fracture	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Infusion Related Reaction	12/235 (5.1%)		13/236 (5.5%)		4/130 (3.1%)
Joint Injury	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Laceration	3/235 (1.3%)		2/236 (0.8%)		2/130 (1.5%)
Muscle Strain	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Procedural Pain	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Radiation Mucositis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Radiation Skin Injury	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Recall Phenomenon	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Rib Fracture	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Scratch	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Subdural Hematoma	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Sunburn	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Toxicity To Various Agents	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Upper Limb Fracture	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Venous Injury	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Wound	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Investigations
Activated Partial Thromboplastin Time Prolonged	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Alanine Aminotransferase	1/235 (0.4%)		3/236 (1.3%)		3/130 (2.3%)
Alanine Aminotransferase Decreased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Alanine Aminotransferase Increased	10/235 (4.3%)		7/236 (3%)		7/130 (5.4%)
Amylase Increased	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Aspartate Aminotransferase	2/235 (0.9%)		2/236 (0.8%)		2/130 (1.5%)
Aspartate Aminotransferase Increased	8/235 (3.4%)		10/236 (4.2%)		7/130 (5.4%)
Biopsy Endometrium	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Blood Albumin	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Blood Albumin Decreased	5/235 (2.1%)		4/236 (1.7%)		1/130 (0.8%)
Blood Alkaline Phosphatase	7/235 (3%)		6/236 (2.5%)		4/130 (3.1%)
Blood Alkaline Phosphatase Decreased	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Blood Alkaline Phosphatase Increased	18/235 (7.7%)		14/236 (5.9%)		6/130 (4.6%)
Blood Bicarbonate Abnormal	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Blood Bicarbonate Decreased	2/235 (0.9%)		0/236 (0%)		1/130 (0.8%)
Blood Bilirubin Decreased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Blood Bilirubin Increased	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Blood Calcium Decreased	2/235 (0.9%)		3/236 (1.3%)		1/130 (0.8%)
Blood Chloride Decreased	2/235 (0.9%)		1/236 (0.4%)		0/130 (0%)
Blood Cholesterol Increased	0/235 (0%)		0/236 (0%)		2/130 (1.5%)
Blood Creatinine	0/235 (0%)		1/236 (0.4%)		3/130 (2.3%)
Blood Creatinine Decreased	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Blood Creatinine Increased	3/235 (1.3%)		4/236 (1.7%)		3/130 (2.3%)
Blood Electrolytes Decreased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Blood Glucose	1/235 (0.4%)		1/236 (0.4%)		1/130 (0.8%)
Blood Glucose Decreased	2/235 (0.9%)		1/236 (0.4%)		0/130 (0%)
Blood Glucose Increased	5/235 (2.1%)		4/236 (1.7%)		1/130 (0.8%)
Blood Lactate Dehydrogenase Increased	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Blood Magnesium	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Blood Magnesium Decreased	18/235 (7.7%)		10/236 (4.2%)		9/130 (6.9%)
Blood Phosphorus Decreased	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Blood Potassium	1/235 (0.4%)		1/236 (0.4%)		1/130 (0.8%)
Blood Potassium Decreased	0/235 (0%)		5/236 (2.1%)		1/130 (0.8%)
Blood Potassium Increased	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Blood Pressure Decreased	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Blood Pressure Increased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Blood Sodium	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Blood Sodium Decreased	1/235 (0.4%)		2/236 (0.8%)		1/130 (0.8%)
Blood Sodium Increased	3/235 (1.3%)		0/236 (0%)		0/130 (0%)
Blood Urea Decreased	5/235 (2.1%)		2/236 (0.8%)		0/130 (0%)
Blood Urea Increased	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Blood Uric Acid Increased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Blood/Bone Marrow Hemoglobin	0/235 (0%)		1/236 (0.4%)		2/130 (1.5%)
Breath Sounds Abnormal	2/235 (0.9%)		1/236 (0.4%)		0/130 (0%)
Chest X-Ray Abnormal	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Coagulation Factor Decreased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Eastern Cooperative Oncology Group Performance Status	44/235 (18.7%)		39/236 (16.5%)		31/130 (23.8%)
Eastern Cooperative Oncology Group Performance Status Worsened	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Ejection Fraction Decreased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Gamma-Glutamyltransferase	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Glomerular Filtration Rate Decreased	0/235 (0%)		0/236 (0%)		2/130 (1.5%)
Heart Rate Irregular	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Hematocrit	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Hematocrit Decreased	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Hematology Test Abnormal	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hemoglobin	16/235 (6.8%)		17/236 (7.2%)		12/130 (9.2%)
Hemoglobin Decreased	11/235 (4.7%)		21/236 (8.9%)		7/130 (5.4%)
Hepatic Enzyme Increased	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Hyperlipidemia	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Hypertriglyceridemia	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
International Normalized Ratio Decreased	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
International Normalized Ratio Increased	3/235 (1.3%)		3/236 (1.3%)		0/130 (0%)
Lymphocyte Count	4/235 (1.7%)		3/236 (1.3%)		1/130 (0.8%)
Lymphocyte Count Decreased	2/235 (0.9%)		1/236 (0.4%)		0/130 (0%)
Metabolic Function Test	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Neutrophil Count	14/235 (6%)		17/236 (7.2%)		10/130 (7.7%)
Neutrophil Count Decreased	12/235 (5.1%)		11/236 (4.7%)		2/130 (1.5%)
Occult Blood Positive	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Oxygen Saturation Decreased	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Platelet Count	7/235 (3%)		15/236 (6.4%)		8/130 (6.2%)
Platelet Count Decreased	7/235 (3%)		22/236 (9.3%)		7/130 (5.4%)
Red Blood Cell Count Decreased	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Staphylococcus Test Positive	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Stool Ph Decreased	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Transaminases Increased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Troponin I Increased	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Urine Color Abnormal	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Urine Output Decreased	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Vitamin B12 Deficiency	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Weight	1/235 (0.4%)		1/236 (0.4%)		1/130 (0.8%)
Weight Decreased	119/235 (50.6%)		100/236 (42.4%)		56/130 (43.1%)
Weight Increased	26/235 (11.1%)		23/236 (9.7%)		13/130 (10%)
Weight Normal	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
White Blood Cell Count	14/235 (6%)		16/236 (6.8%)		16/130 (12.3%)
White Blood Cell Count Decreased	2/235 (0.9%)		6/236 (2.5%)		0/130 (0%)
White Blood Cell Count Increased	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Metabolism and nutrition disorders
Cachexia	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Decreased Appetite	74/235 (31.5%)		63/236 (26.7%)		44/130 (33.8%)
Dehydration	29/235 (12.3%)		19/236 (8.1%)		12/130 (9.2%)
Diabetes Mellitus	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Electrolyte Imbalance	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Failure To Thrive	1/235 (0.4%)		3/236 (1.3%)		0/130 (0%)
Glucose Tolerance Impaired	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Gout	1/235 (0.4%)		1/236 (0.4%)		1/130 (0.8%)
Hypercalcemia	1/235 (0.4%)		7/236 (3%)		3/130 (2.3%)
Hypercholesterolemia	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Hyperglycemia	23/235 (9.8%)		15/236 (6.4%)		16/130 (12.3%)
Hyperkalemia	5/235 (2.1%)		5/236 (2.1%)		4/130 (3.1%)
Hypermagnesemia	1/235 (0.4%)		2/236 (0.8%)		5/130 (3.8%)
Hypernatremia	0/235 (0%)		2/236 (0.8%)		3/130 (2.3%)
Hypoalbuminemia	13/235 (5.5%)		18/236 (7.6%)		9/130 (6.9%)
Hypocalcemia	12/235 (5.1%)		16/236 (6.8%)		13/130 (10%)
Hypoglycemia	1/235 (0.4%)		4/236 (1.7%)		3/130 (2.3%)
Hypokalemia	34/235 (14.5%)		24/236 (10.2%)		22/130 (16.9%)
Hypomagnesemia	80/235 (34%)		64/236 (27.1%)		37/130 (28.5%)
Hyponatremia	17/235 (7.2%)		18/236 (7.6%)		16/130 (12.3%)
Hypophosphatemia	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Hypovolemia	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Lactic Acidosis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Magnesium Metabolism Disorder	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Malnutrition	2/235 (0.9%)		1/236 (0.4%)		0/130 (0%)
Weight Fluctuation	3/235 (1.3%)		5/236 (2.1%)		2/130 (1.5%)
Musculoskeletal and connective tissue disorders
Arthralgia	31/235 (13.2%)		15/236 (6.4%)		4/130 (3.1%)
Arthritis	3/235 (1.3%)		0/236 (0%)		0/130 (0%)
Back Pain	24/235 (10.2%)		25/236 (10.6%)		21/130 (16.2%)
Bone Pain	17/235 (7.2%)		7/236 (3%)		3/130 (2.3%)
Bursitis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Chest Wall Cyst	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Costochondritis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Fibromyalgia	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Flank Pain	4/235 (1.7%)		2/236 (0.8%)		3/130 (2.3%)
Groin Pain	2/235 (0.9%)		1/236 (0.4%)		0/130 (0%)
Intervertebral Disc Protusion	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Joint Stiffness	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Joint Swelling	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Limb Discomfort	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Muscle Spasms	3/235 (1.3%)		2/236 (0.8%)		3/130 (2.3%)
Muscle Twitching	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Muscular Weakness	9/235 (3.8%)		12/236 (5.1%)		13/130 (10%)
Musculoskeletal Chest Pain	9/235 (3.8%)		11/236 (4.7%)		9/130 (6.9%)
Musculoskeletal Discomfort	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Musculoskeletal Disorder	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Musculoskeletal Pain	15/235 (6.4%)		9/236 (3.8%)		3/130 (2.3%)
Myalgia	16/235 (6.8%)		5/236 (2.1%)		3/130 (2.3%)
Myopathy	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Neck Pain	1/235 (0.4%)		5/236 (2.1%)		4/130 (3.1%)
Osteopenia	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Osteoporosis	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Pain In Extremity	25/235 (10.6%)		16/236 (6.8%)		10/130 (7.7%)
Pathological Fracture	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Periarthritis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Scleroderma	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Metastasis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Metastatic Pain	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Skin Papilloma	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Tumor Pain	2/235 (0.9%)		1/236 (0.4%)		0/130 (0%)
Nervous system disorders
7th Nerve Paralysis	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Ataxia	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Balance Disorder	1/235 (0.4%)		2/236 (0.8%)		1/130 (0.8%)
Burning Sensation	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Central Nervous System Hemorrhage	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Cognitive Disorder	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Convulsion	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Dizziness	26/235 (11.1%)		32/236 (13.6%)		22/130 (16.9%)
Dysgeusia	21/235 (8.9%)		24/236 (10.2%)		3/130 (2.3%)
Dyskinesia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Facial Paresis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Headache	26/235 (11.1%)		25/236 (10.6%)		19/130 (14.6%)
Hemiparesis	0/235 (0%)		1/236 (0.4%)		2/130 (1.5%)
Hyperreflexia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hypersomnia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hypoesthesia	8/235 (3.4%)		4/236 (1.7%)		8/130 (6.2%)
Loss Of Consciousness	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Memory Impairment	5/235 (2.1%)		2/236 (0.8%)		3/130 (2.3%)
Migraine	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Muscle Contractions Involuntary	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Nervousness	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Neuralgia	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Neuropathy Peripheral	54/235 (23%)		11/236 (4.7%)		4/130 (3.1%)
Paresthesia	7/235 (3%)		2/236 (0.8%)		8/130 (6.2%)
Peripheral Motor Neuropathy	3/235 (1.3%)		1/236 (0.4%)		2/130 (1.5%)
Peripheral Sensorimotor Neuropathy	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Peripheral Sensory Neuropathy	36/235 (15.3%)		6/236 (2.5%)		4/130 (3.1%)
Peroneal Nerve Palsy	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Phantom Pain	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Post Herpetic Neuralgia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Presyncope	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Restless Legs Syndrome	2/235 (0.9%)		3/236 (1.3%)		0/130 (0%)
Sensory Loss	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Sinus Headache	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Slow Speech	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Somnolence	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Syncope	5/235 (2.1%)		4/236 (1.7%)		2/130 (1.5%)
Tension Headache	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Tremor	2/235 (0.9%)		11/236 (4.7%)		4/130 (3.1%)
Trigeminal Neuralgia	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Psychiatric disorders
Abnormal Dreams	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Agitation	1/235 (0.4%)		3/236 (1.3%)		2/130 (1.5%)
Anxiety	17/235 (7.2%)		17/236 (7.2%)		9/130 (6.9%)
Confusional State	14/235 (6%)		7/236 (3%)		4/130 (3.1%)
Depression	17/235 (7.2%)		11/236 (4.7%)		9/130 (6.9%)
Euphoric Mood	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Hallucination	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Insomnia	31/235 (13.2%)		32/236 (13.6%)		16/130 (12.3%)
Major Depression	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Mental Status Changes	3/235 (1.3%)		0/236 (0%)		0/130 (0%)
Mood Altered	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Personality Change	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Restlessness	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Sleep Disorder	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Tearfulness	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Renal and urinary disorders
Anuria	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Bladder Pain	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Dysuria	3/235 (1.3%)		7/236 (3%)		2/130 (1.5%)
Hematuria	3/235 (1.3%)		3/236 (1.3%)		0/130 (0%)
Incontinence	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Micturition Urgency	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Nocturia	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Pollakiuria	2/235 (0.9%)		0/236 (0%)		3/130 (2.3%)
Polyuria	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Proteinuria	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Renal Failure	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Renal Failure Chronic	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Renal Impairment	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Urinary Bladder Hemorrhage	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Urinary Incontinence	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Urinary Retention	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Urine Flow Decreased	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Reproductive system and breast disorders
Benign Prostatic Hyperplasia	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Breast Mass	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Breast Pain	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Dysfunctional Uterine Bleeding	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Epididymitis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Erectile Dysfunction	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Genital Burning Sensation	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Pelvic Pain	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Penile Swelling	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Vaginal Hemorrhage	0/235 (0%)		1/236 (0.4%)		2/130 (1.5%)
Vulvovaginal Erythema	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Respiratory, thoracic and mediastinal disorders
Asthma	0/235 (0%)		0/236 (0%)		2/130 (1.5%)
Bronchospasm	1/235 (0.4%)		1/236 (0.4%)		1/130 (0.8%)
Chronic Obstructive Pulmonary Disease	6/235 (2.6%)		1/236 (0.4%)		2/130 (1.5%)
Cough	41/235 (17.4%)		52/236 (22%)		22/130 (16.9%)
Dysphonia	5/235 (2.1%)		2/236 (0.8%)		1/130 (0.8%)
Dyspnea	62/235 (26.4%)		74/236 (31.4%)		36/130 (27.7%)
Dyspnea Exertional	8/235 (3.4%)		13/236 (5.5%)		6/130 (4.6%)
Epistaxis	28/235 (11.9%)		33/236 (14%)		16/130 (12.3%)
Hemoptysis	9/235 (3.8%)		13/236 (5.5%)		4/130 (3.1%)
Hiccups	2/235 (0.9%)		5/236 (2.1%)		0/130 (0%)
Hydropneumothorax	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Hypoxia	7/235 (3%)		4/236 (1.7%)		3/130 (2.3%)
Increased Upper Airway Secretion	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Lung Infiltration	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Nasal Congestion	1/235 (0.4%)		4/236 (1.7%)		0/130 (0%)
Nasal Discharge Discoloration	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Nasal Discomfort	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Nasal Dryness	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Oropharyngeal Pain	7/235 (3%)		6/236 (2.5%)		3/130 (2.3%)
Painful Respiration	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Paranasal Sinus Discomfort	1/235 (0.4%)		1/236 (0.4%)		1/130 (0.8%)
Paranasal Sinus Hypersecretion	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Pleural Effusion	2/235 (0.9%)		5/236 (2.1%)		4/130 (3.1%)
Pleural Fibrosis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Pleuritic Pain	0/235 (0%)		3/236 (1.3%)		1/130 (0.8%)
Pneumothorax	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Productive Cough	6/235 (2.6%)		6/236 (2.5%)		3/130 (2.3%)
Pulmonary Congestion	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Pulmonary Embolism	3/235 (1.3%)		2/236 (0.8%)		3/130 (2.3%)
Pulmonary Hemorrhage	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Rales	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Respiratory Depression	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Respiratory Disorder	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Respiratory Distress	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Respiratory Tract Congestion	1/235 (0.4%)		2/236 (0.8%)		0/130 (0%)
Rhinitis Allergic	5/235 (2.1%)		0/236 (0%)		1/130 (0.8%)
Rhinorrhea	10/235 (4.3%)		6/236 (2.5%)		5/130 (3.8%)
Rhonchi	2/235 (0.9%)		1/236 (0.4%)		1/130 (0.8%)
Sinus Congestion	1/235 (0.4%)		3/236 (1.3%)		0/130 (0%)
Sputum Discolored	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Stridor	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Upper Respiratory Tract Congestion	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Upper-Airway Cough Syndrome	1/235 (0.4%)		2/236 (0.8%)		1/130 (0.8%)
Wheezing	4/235 (1.7%)		6/236 (2.5%)		3/130 (2.3%)
Skin and subcutaneous tissue disorders
Acne	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Alopecia	53/235 (22.6%)		27/236 (11.4%)		6/130 (4.6%)
Anhidrosis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Blister	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Decubitus Ulcer	5/235 (2.1%)		4/236 (1.7%)		1/130 (0.8%)
Dermal Cyst	0/235 (0%)		2/236 (0.8%)		0/130 (0%)
Dermatitis	5/235 (2.1%)		1/236 (0.4%)		4/130 (3.1%)
Dermatitis Acneiform	68/235 (28.9%)		55/236 (23.3%)		32/130 (24.6%)
Dry Skin	27/235 (11.5%)		31/236 (13.1%)		13/130 (10%)
Ecchymosis	4/235 (1.7%)		1/236 (0.4%)		0/130 (0%)
Erythema	3/235 (1.3%)		3/236 (1.3%)		5/130 (3.8%)
Exfoliative Rash	5/235 (2.1%)		2/236 (0.8%)		4/130 (3.1%)
Hair Disorder	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hair Growth Abnormal	0/235 (0%)		1/236 (0.4%)		2/130 (1.5%)
Hirsutism	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hyperhidrosis	3/235 (1.3%)		2/236 (0.8%)		2/130 (1.5%)
Ingrowing Nail	2/235 (0.9%)		0/236 (0%)		0/130 (0%)
Lip Ulceration	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Madarosis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Nail Discoloration	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Nail Disorder	8/235 (3.4%)		5/236 (2.1%)		2/130 (1.5%)
Night Sweats	7/235 (3%)		6/236 (2.5%)		3/130 (2.3%)
Onychalgia	1/235 (0.4%)		2/236 (0.8%)		1/130 (0.8%)
Pain Of Skin	3/235 (1.3%)		1/236 (0.4%)		1/130 (0.8%)
Palmar-Plantar Erythrodysesthesia Syndrome	6/235 (2.6%)		3/236 (1.3%)		3/130 (2.3%)
Penile Ulceration	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Petechiae	1/235 (0.4%)		8/236 (3.4%)		1/130 (0.8%)
Photosensitivity Reaction	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Pruritus	17/235 (7.2%)		22/236 (9.3%)		2/130 (1.5%)
Pruritus Generalized	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Psoriasis	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Rash	88/235 (37.4%)		100/236 (42.4%)		51/130 (39.2%)
Rash Erythematous	1/235 (0.4%)		0/236 (0%)		2/130 (1.5%)
Rash Macular	2/235 (0.9%)		1/236 (0.4%)		1/130 (0.8%)
Rash Maculo-Papular	2/235 (0.9%)		1/236 (0.4%)		0/130 (0%)
Rash Papular	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Rash Pruritic	1/235 (0.4%)		1/236 (0.4%)		0/130 (0%)
Scab	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Skin Atrophy	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Skin Depigmentation	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Skin Discoloration	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Skin Disorder	2/235 (0.9%)		0/236 (0%)		3/130 (2.3%)
Skin Exfoliation	3/235 (1.3%)		2/236 (0.8%)		1/130 (0.8%)
Skin Fissures	1/235 (0.4%)		4/236 (1.7%)		1/130 (0.8%)
Skin Hyperpigmentation	5/235 (2.1%)		1/236 (0.4%)		1/130 (0.8%)
Skin Irritation	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Skin Lesion	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Skin Necrosis	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Skin Ulcer	3/235 (1.3%)		0/236 (0%)		1/130 (0.8%)
Subcutaneous Abscess	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Subcutaneous Emphysema	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Swelling Face	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Urticaria	2/235 (0.9%)		2/236 (0.8%)		0/130 (0%)
Social circumstances
Tobacco User	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Surgical and medical procedures
Abscess Drainage	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Atrial Septal Defect Repair	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Catheter Placement	1/235 (0.4%)		2/236 (0.8%)		0/130 (0%)
Central Venous Catheterization	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Cholelithotomy	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Colony Stimulating Factor Therapy	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Medical Device Change	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Nail Operation	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Pleurodesis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Sinus Operation	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Skin Lesion Excision	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Therapy Regimen Changed	1/235 (0.4%)		0/236 (0%)		1/130 (0.8%)
Vascular disorders
Arteriosclerosis	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Deep Vein Thrombosis	7/235 (3%)		6/236 (2.5%)		2/130 (1.5%)
Embolism	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Flushing	4/235 (1.7%)		7/236 (3%)		2/130 (1.5%)
Hematoma	3/235 (1.3%)		0/236 (0%)		0/130 (0%)
Hemorrhage	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Hot Flush	1/235 (0.4%)		1/236 (0.4%)		3/130 (2.3%)
Hypertension	5/235 (2.1%)		3/236 (1.3%)		7/130 (5.4%)
Hypotension	29/235 (12.3%)		14/236 (5.9%)		10/130 (7.7%)
Intermittent Claudication	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Ischemia	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Jugular Vein Thrombosis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Kawasaki's Disease	0/235 (0%)		0/236 (0%)		1/130 (0.8%)
Lymphedema	1/235 (0.4%)		0/236 (0%)		0/130 (0%)
Orthostatic Hypotension	3/235 (1.3%)		1/236 (0.4%)		2/130 (1.5%)
Pallor	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Peripheral Embolism	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Phlebitis Superficial	0/235 (0%)		1/236 (0.4%)		1/130 (0.8%)
Raynaud's Phenomenon	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Thrombophlebitis	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Thrombophlebitis Superficial	0/235 (0%)		1/236 (0.4%)		0/130 (0%)
Thrombosis	0/235 (0%)		2/236 (0.8%)		1/130 (0.8%)
Venous Insufficiency	0/235 (0%)		0/236 (0%)		1/130 (0.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The study funder will be provided with a copy of any results communication at least 30 days prior to its submission to a scientific journal or presentation at a scientific meeting to allow review of the publication for confidential information. If confidential information is being disclosed, it may be required to be redacted. Upon request by the study funder, the PI may be asked to withhold disclosure for an additional 90 days to allow the study funder to seek patent protection.