Trial Outcomes & Findings for S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NCT NCT00946712)

Last Updated: 2023-05-23

Results Overview

From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

1333 participants

Primary outcome timeframe

Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years

Results posted on

2023-05-23

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Chemo +/- Bevacizumab) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Arm II (Chemo, Cetuximab, +/- Bevacizumab) Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Cetuximab: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Overall Study STARTED	671	662
Overall Study COMPLETED	124	0
Overall Study NOT COMPLETED	547	662

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Chemo +/- Bevacizumab) Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Arm II (Chemo, Cetuximab, +/- Bevacizumab) Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Cetuximab: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Overall Study Adverse Event	118	124
Overall Study Disease progression	308	404
Overall Study Death	21	22
Overall Study No treatment given	25	29
Overall Study Other reasons	61	73
Overall Study On Treatment	0	4
Overall Study Ineligible	14	6

Baseline Characteristics

S0819: Carboplatin and Paclitaxel With or Without Bevacizumab and/or Cetuximab in Treating Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Chemo +/- Bevacizumab) n=657 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Arm II (Chemo, Cetuximab, +/- Bevacizumab) n=656 Participants Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Cetuximab: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Total n=1313 Participants Total of all reporting groups
Age, Continuous	63 years n=5 Participants	63 years n=7 Participants	63 years n=5 Participants
Age, Customized Age, Categorized · Age <= 65	379 Participants n=5 Participants	381 Participants n=7 Participants	760 Participants n=5 Participants
Age, Customized Age, Categorized · Age > 65	278 Participants n=5 Participants	275 Participants n=7 Participants	553 Participants n=5 Participants
Sex: Female, Male Female	298 Participants n=5 Participants	271 Participants n=7 Participants	569 Participants n=5 Participants
Sex: Female, Male Male	359 Participants n=5 Participants	385 Participants n=7 Participants	744 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	26 Participants n=5 Participants	16 Participants n=7 Participants	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	606 Participants n=5 Participants	618 Participants n=7 Participants	1224 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	25 Participants n=5 Participants	22 Participants n=7 Participants	47 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	565 Participants n=5 Participants	568 Participants n=7 Participants	1133 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black	61 Participants n=5 Participants	55 Participants n=7 Participants	116 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	10 Participants n=5 Participants	18 Participants n=7 Participants	28 Participants n=5 Participants
Race/Ethnicity, Customized Race · Pacific Islander	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Race · Native American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race · Unknown	16 Participants n=5 Participants	8 Participants n=7 Participants	24 Participants n=5 Participants
M-stage M1a	148 Participants n=5 Participants	150 Participants n=7 Participants	298 Participants n=5 Participants
M-stage M1b	509 Participants n=5 Participants	506 Participants n=7 Participants	1015 Participants n=5 Participants
Bevacizumab treatment Yes	277 Participants n=5 Participants	283 Participants n=7 Participants	560 Participants n=5 Participants
Bevacizumab treatment No	380 Participants n=5 Participants	373 Participants n=7 Participants	753 Participants n=5 Participants
Smoking History Current	297 Participants n=5 Participants	292 Participants n=7 Participants	589 Participants n=5 Participants
Smoking History Former	303 Participants n=5 Participants	305 Participants n=7 Participants	608 Participants n=5 Participants
Smoking History Never	57 Participants n=5 Participants	59 Participants n=7 Participants	116 Participants n=5 Participants
Histology Squamous cell carcinoma	161 Participants n=5 Participants	160 Participants n=7 Participants	321 Participants n=5 Participants
Histology Adenocarcinoma	408 Participants n=5 Participants	411 Participants n=7 Participants	819 Participants n=5 Participants
Histology Other	88 Participants n=5 Participants	85 Participants n=7 Participants	173 Participants n=5 Participants
Performance Status 0	229 Participants n=5 Participants	256 Participants n=7 Participants	485 Participants n=5 Participants
Performance Status 1	427 Participants n=5 Participants	400 Participants n=7 Participants	827 Participants n=5 Participants
Performance Status Missing Data	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
EGFR (Epidermal Growth Factor Receptor) FISH (Fluorescence In Situ Hybridization) status Positive	201 Participants n=5 Participants	199 Participants n=7 Participants	400 Participants n=5 Participants
EGFR (Epidermal Growth Factor Receptor) FISH (Fluorescence In Situ Hybridization) status Negative	293 Participants n=5 Participants	283 Participants n=7 Participants	576 Participants n=5 Participants
EGFR (Epidermal Growth Factor Receptor) FISH (Fluorescence In Situ Hybridization) status Unknown	163 Participants n=5 Participants	174 Participants n=7 Participants	337 Participants n=5 Participants

PRIMARY outcome

Timeframe: Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years

Population: All eligible patients are included in the analysis.

From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Outcome measures
Measure	Arm I (Chemo +/- Bevacizumab) n=657 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Arm II (Chemo, Cetuximab, +/- Bevacizumab) n=656 Participants Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Cetuximab: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Overall Survival (OS) in the Entire Study Population	9.2 months Interval 8.7 to 10.3	10.9 months Interval 9.5 to 12.0

PRIMARY outcome

Timeframe: Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.

Population: Eligible patients with EGFR FISH positive are included in the analysis.

From date of randomization to date of first documentation of progression or symptomatic deterioration, or death due to any cause, whichever comes first by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as assessed by the treating investigator.Patients last known to be alive and progression-free are censored at date of last contact. Progression is defined using RECIST 1.1, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Outcome measures

Outcome measures
Measure	Arm I (Chemo +/- Bevacizumab) n=201 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Arm II (Chemo, Cetuximab, +/- Bevacizumab) n=199 Participants Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Cetuximab: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Progression-free Survival (PFS) of EGFR FISH-positive Patients by Institutional Review	4.8 months Interval 3.9 to 5.5	5.4 months Interval 4.5 to 5.7

SECONDARY outcome

Timeframe: Patients will be followed every 3 weeks while on protocol treatment. Once off all protocol treatment, patients will be followed every 6 months until death or up to 3 years

Population: Eligible and evaluable participants who were EGFR-FISH positive

From date of randomization to date of death due to any cause. Patients last known to be alive are censored at date of last contact.

Outcome measures

Outcome measures
Measure	Arm I (Chemo +/- Bevacizumab) n=201 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Arm II (Chemo, Cetuximab, +/- Bevacizumab) n=199 Participants Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Cetuximab: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Overall Survival (OS) of EGFR FISH-positive Patients	9.8 Months Interval 8.7 to 12.1	13.4 Months Interval 11.5 to 14.8

SECONDARY outcome

Timeframe: Disease assessment will be repeated every 6 weeks until disease progression while on treatment. After off treatment, the frequency of disease assessment may be reduced to every 3 months until disease progression.

Population: Data are not available for this outcome as central image review was not performed. The study was closed for futility at the interim analysis and therefore there was no need to confirm PFS by central review.

Outcome measures

Outcome data not reported

SECONDARY outcome

Population: Eligible and evaluable participants

Outcome measures

Outcome measures
Measure	Arm I (Chemo +/- Bevacizumab) n=657 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Arm II (Chemo, Cetuximab, +/- Bevacizumab) n=656 Participants Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Cetuximab: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Progression-Free Survival (PFS) of the Entire Study Population by Institutional Review	4.5 Months Interval 4.2 to 5.1	4.6 Months Interval 4.2 to 5.2

SECONDARY outcome

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.

Population: Eligible EGFR FISH positive patients with baseline measurable disease are included in the analysis.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Outcome measures

Outcome measures
Measure	Arm I (Chemo +/- Bevacizumab) n=191 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Arm II (Chemo, Cetuximab, +/- Bevacizumab) n=187 Participants Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Cetuximab: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in EGFR FISH-positive Patients	43 percentage of analyzed participants Interval 36.0 to 50.0	47 percentage of analyzed participants Interval 39.0 to 54.0

SECONDARY outcome

Timeframe: Disease assessment will be repeated every 6 weeks for the first 9 months and every 3 months thereafter, until disease progression.

Population: Eligible patients with baseline measurable disease are included in the analysis.

Outcome measures

Outcome measures
Measure	Arm I (Chemo +/- Bevacizumab) n=623 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Arm II (Chemo, Cetuximab, +/- Bevacizumab) n=617 Participants Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Cetuximab: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Response Rate (Confirmed Plus Unconfirmed, Complete and Partial Responses) in the Subset of Patients With Measurable Disease in the Entire Study Population	36 percentage of analyzed participants Interval 33.0 to 40.0	42 percentage of analyzed participants Interval 38.0 to 46.0

SECONDARY outcome

Timeframe: Toxicity assessment was evaluated every 3 weeks while one protocol treatment. Chemo and cetuximab is treated for 6 cycles (1 cycle =3 weeks) and Bevacizumab is treated until progression or unacceptable toxicity.

Population: Limited to eligible patients who started treatment, who did not have a major deviation in the treatment protocol, and whose toxicity profile has been completed.

Adverse Events (AEs) are reported by CTCAE Version 4.0. Only adverse events that are possibly, probably or definitely related to study drug are reported.

Outcome measures

Outcome measures
Measure	Arm I (Chemo +/- Bevacizumab) n=632 Participants Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes with or without bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients receiving bevacizumab may continue to receive bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV	Arm II (Chemo, Cetuximab, +/- Bevacizumab) n=627 Participants Patients receive paclitaxel and carboplatin with or without bevacizumab as in Arm I. Patients also receive cetuximab IV over 1-2 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients may continue to receive cetuximab with or without bevacizumab (as above) in the absence of disease progression or unacceptable toxicity. Bevacizumab: Given IV Carboplatin: Given IV Cetuximab: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infection with unknown ANC - Eye NOS	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infection with unknown ANC - Lung (pneumonia)	5 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infection with unknown ANC - Sinus	2 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infection with unknown ANC - Skin (cellulitis)	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs ALT, SGPT (serum glutamic pyruvic transaminase)	5 Participants	8 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs AST, SGOT	6 Participants	8 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Acidosis (metabolic or respiratory)	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Adrenal insufficiency	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Albumin, serum-low (hypoalbuminemia)	8 Participants	7 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Alkaline phosphatase	2 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Calcium, serum-high (hypercalcemia)	2 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Carbon monoxide diffusion capacity (DL(co))	3 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Cardiac General-Other (Specify)	2 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Cardiac troponin I (cTnI)	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Cardiac-ischemia/infarction	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Colitis	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Colitis, infectious (e.g., Clostridium difficile)	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Constipation	4 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Cough	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Death not associated with CTCAE term - Death NOS	1 Participants	7 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dehydration	27 Participants	31 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dry skin	0 Participants	6 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dysphagia (difficulty swallowing)	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dyspnea (shortness of breath)	21 Participants	33 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Glucose, serum-high (hyperglycemia)	20 Participants	13 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - UTI	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Bladder	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infection with unknown ANC - Wound	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infection-Other (Specify)	4 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Insomnia	1 Participants	5 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Irregular menses (change from baseline)	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neuroendocrine: ADH secretion abnormality	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neuropathy: motor	18 Participants	10 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neutrophils/granulocytes (ANC/AGC)	158 Participants	210 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Obstruction, GI - Small bowel NOS	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Oral cavity	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Peritoneum	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pancreatitis	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Perforation, GI - Colon	1 Participants	6 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Perforation, GI - Small bowel NOS	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pericardial effusion (non-malignant)	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs SVT and nodal arrhythmia - Atrial fibrillation	2 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis/stomatitis (clinical exam) - Esophagus	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis/stomatitis (clinical exam) - Oral cavity	2 Participants	6 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Allergic reaction/hypersensitivity	9 Participants	41 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Allergy/Immunology-Other (Specify)	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Anorexia	22 Participants	25 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Apnea	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Aspiration	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Ataxia (incoordination)	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Bilirubin (hyperbilirubinemia)	2 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Blood/Bone Marrow-Other (Specify)	2 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Bronchospasm, wheezing	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs CNS cerebrovascular ischemia	2 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Calcium, serum-low (hypocalcemia)	1 Participants	8 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Cardiopulmonary arrest, cause unknown (non-fatal)	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Cognitive disturbance	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Conduction abnormality - Asystole	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Confusion	1 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Creatinine	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Cytokine release syndrome/acute infusion reaction	0 Participants	10 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Death - Multi-organ failure	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dermatology/Skin-Other (Specify)	0 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Diarrhea	15 Participants	19 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dizziness	10 Participants	7 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dry eye syndrome	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Dry mouth/salivary gland (xerostomia)	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Edema: limb	1 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Encephalopathy	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Esophagitis	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Extrapyramidal/involuntary movement/restlessness	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Eyelid dysfunction	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fatigue (asthenia, lethargy, malaise)	74 Participants	81 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Febrile neutropenia	27 Participants	29 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Fever in absence of neutropenia, ANC lt1.0x10e9/L	2 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs GGT (gamma-glutamyl transpeptidase)	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Gastritis (including bile reflux gastritis)	0 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Gastrointestinal-Other (Specify)	1 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Glucose, serum-low (hypoglycemia)	2 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Heartburn/dyspepsia	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemoglobin	60 Participants	48 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemolysis	0 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, GI - Abdomen NOS	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, GI - Duodenum	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, GI - Esophagus	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, GI - Jejunum	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, GI - Lower GI NOS	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, GI - Upper GI NOS	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, GI - Varices (esophageal)	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, GI - Varices (rectal)	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, pulmo/upper resp- Bronchopulmonary NOS	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, pulmonary/upper respiratory - Lung	1 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, pulmonary/upper respiratory - Nose	2 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage, pulmonary/upper respiratory - Pleura	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hemorrhage/Bleeding-Other (Specify)	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hiccoughs (hiccups, singultus)	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hot flashes/flushes	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypertension	28 Participants	17 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypotension	5 Participants	11 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Hypoxia	2 Participants	6 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs INR (of prothrombin time)	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - Blood	8 Participants	10 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - Bronchus	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - Catheter-rel	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - Colon	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - Duodenum	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - Esophagus	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - Lung	9 Participants	7 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - Oral cav-gums	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - Pleura	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf (clin/microbio) w/Gr 3-4 neuts - Skin	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Blood	2 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Catheter	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Dental	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Joint	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Lung	11 Participants	8 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Mucosa	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Pelvis	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Perit cav	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Pleura	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - Skin	0 Participants	5 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Inf w/normal ANC or Gr 1-2 neutrophils - UTI	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infection with unknown ANC - Blood	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mucositis/stomatitis (functional/symp) - Oral cav	0 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infection with unknown ANC - Upper airway NOS	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Infection with unknown ANC - Urinary tract NOS	2 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Leukocytes (total WBC)	74 Participants	103 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Leukoencephalopathy (radiolographic findings)	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Local complication - device/prosthesis-related	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Lymphopenia	39 Participants	60 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Magnesium, serum-high (hypermagnesemia)	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Magnesium, serum-low (hypomagnesemia)	6 Participants	28 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Memory impairment	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mental status	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Metabolic/Laboratory-Other (Specify)	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mood alteration - anxiety	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Mood alteration - depression	3 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Muscle weakness, not d/t neuropathy - Extrem-lower	6 Participants	9 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Muscle weakness, not d/t neuropathy - Extrem-upper	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Muscle weakness, not d/t neuropathy - Pelvic	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Muscle weakness, not d/t neuropathy - body/general	21 Participants	33 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Nail changes	0 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Nasal cavity/paranasal sinus reactions	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Nausea	26 Participants	30 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Neuropathy: sensory	57 Participants	36 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Obstruction/stenosis of airway - Bronchus	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Ocular/Visual-Other (Specify)	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Opportunistic inf associated w/gt=Gr 2 lymphopenia	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Abdomen NOS	5 Participants	9 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Back	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Bone	2 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Chest wall	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Chest/thorax NOS	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Extremity-limb	10 Participants	12 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Head/headache	2 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Joint	19 Participants	19 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Muscle	24 Participants	14 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Neck	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Neuralgia/peripheral nerve	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Scrotum	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Skin	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain - Stomach	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pain-Other (Specify)	2 Participants	3 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Perforation, GI - Duodenum	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Phosphate, serum-low (hypophosphatemia)	2 Participants	8 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Platelets	51 Participants	43 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pleural effusion (non-malignant)	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pneumonitis/pulmonary infiltrates	2 Participants	8 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Potassium, serum-high (hyperkalemia)	1 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Potassium, serum-low (hypokalemia)	22 Participants	35 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Proteinuria	4 Participants	7 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pruritus/itching	0 Participants	7 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Pulmonary/Upper Respiratory-Other (Specify)	2 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Rash/desquamation	1 Participants	6 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Rash: acne/acneiform	0 Participants	50 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Rash: hand-foot skin reaction	0 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Renal failure	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Renal/Genitourinary-Other (Specify)	3 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs SVT and nodal arrhythmia - Atrial flutter	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs SVT and nodal arrhythmia - SVT tachycardia	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs SVT and nodal arrhythmia - Sinus tachycardia	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Seizure	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Sodium, serum-low (hyponatremia)	29 Participants	27 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Somnolence/depressed level of consciousness	1 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Sudden death	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Syncope (fainting)	8 Participants	7 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Syndromes-Other (Specify)	0 Participants	2 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Thrombosis/embolism (vascular access-related)	0 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Thrombosis/thrombus/embolism	26 Participants	37 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Tinnitus	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Tremor	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Tumor lysis syndrome	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Typhlitis (cecal inflammation)	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Ulcer, GI - Duodenum	1 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Ulcer, GI - Stomach	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Ulceration	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Uric acid, serum-high (hyperuricemia)	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Urticaria (hives, welts, wheals)	0 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Ventricular arrhythmia - Ventricular tachycardia	1 Participants	0 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Ventricular arrhythmia NOS	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Visceral arterial ischemia (non-myocardial)	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Vomiting	19 Participants	18 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Weight gain	0 Participants	1 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Weight loss	8 Participants	4 Participants
Number of Patients With Gr 3 Through 5 Adverse Events That Are Related to Study Drugs Wound complication, non-infectious	0 Participants	1 Participants

Adverse Events

Arm I (Chemo +/- Bevacizumab)

Serious events: 66 serious events

Other events: 619 other events

Deaths: 593 deaths

Arm II (Chemo, Cetuximab, +/- Bevacizumab)

Serious events: 97 serious events

Other events: 611 other events

Deaths: 570 deaths

Serious adverse events

Other adverse events

Additional Information

Lung Committee Statistican

SWOG Statistics & Data Management Center

Phone: 2066675712

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60