Trial Outcomes & Findings for Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery (NCT NCT00326898)

NCT ID: NCT00326898

Last Updated: 2022-02-08

Results Overview

Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1943 participants
• Primary outcome timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry
• Results posted on: 2022-02-08

Participant Flow

The study was activated on April 24, 2006 and closed to accrual on September 1, 2010, after accrual of 1943 patients.

Participant milestones

Measure	Arm A (Sunitinib + Sorafenib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.	Arm B (Sorafenib + Sunitinib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.	Arm C (Sunitinib Placebo + Sorafenib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Overall Study STARTED	647	649	647
Overall Study Patients With Toxicity Data	625	628	626
Overall Study Patients With Clear Cell Histology	542	540	540
Overall Study Patients With >=1 Follow-up MUGA Scan	513	510	580
Overall Study COMPLETED	296	306	444
Overall Study NOT COMPLETED	351	343	203

Reasons for withdrawal

Measure	Arm A (Sunitinib + Sorafenib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.	Arm B (Sorafenib + Sunitinib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.	Arm C (Sunitinib Placebo + Sorafenib Placebo) Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Overall Study Disease progression	52	54	102
Overall Study Adverse Event	124	128	33
Overall Study Death	2	0	0
Overall Study Withdrawal by Subject	134	128	32
Overall Study Alternative therapy	1	0	0
Overall Study Other complicating disease	5	5	4
Overall Study Other/Missing/Unknown	33	28	32

Baseline Characteristics

Sunitinib Malate or Sorafenib Tosylate in Treating Patients With Kidney Cancer That Was Removed By Surgery

Baseline characteristics by cohort

Measure	Arm A (Sunitinib + Sorafenib Placebo) n=647 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.	Arm B (Sorafenib + Sunitinib Placebo) n=649 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.	Arm C (Sunitinib Placebo + Sorafenib Placebo) n=647 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.	Total n=1943 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	489 Participants n=93 Participants	507 Participants n=4 Participants	500 Participants n=27 Participants	1496 Participants n=483 Participants
Age, Categorical >=65 years	158 Participants n=93 Participants	142 Participants n=4 Participants	147 Participants n=27 Participants	447 Participants n=483 Participants
Sex: Female, Male Female	218 Participants n=93 Participants	212 Participants n=4 Participants	204 Participants n=27 Participants	634 Participants n=483 Participants
Sex: Female, Male Male	429 Participants n=93 Participants	437 Participants n=4 Participants	443 Participants n=27 Participants	1309 Participants n=483 Participants

PRIMARY outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Population: All randomized patients

Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation.

Outcome measures

Measure	Arm A (Sunitinib + Sorafenib Placebo) n=647 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.	Arm B (Sorafenib + Sunitinib Placebo) n=649 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.	Arm C (Sunitinib Placebo + Sorafenib Placebo) n=647 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Disease-free Survival (DFS)	5.8 years Interval 5.0 to The upper limit of the 97.5% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	6.1 years Interval 4.8 to The upper limit of the 97.5% confidence interval was not calculable because an insufficient number of participants reached the event at the final time point for assessment.	6.6 years Interval 5.3 to 7.8

SECONDARY outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry

Population: All randomized patients

Overall survival is defined as the time from randomization to death from any cause. Patients without a date of death were censored at the date of last contact. Kaplan-Meier method was used to estimate 5-year survival rate.

Outcome measures

Measure	Arm A (Sunitinib + Sorafenib Placebo) n=647 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.	Arm B (Sorafenib + Sunitinib Placebo) n=649 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.	Arm C (Sunitinib Placebo + Sorafenib Placebo) n=647 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
5-year Overall Survival Rate	0.779 proportion of participants Interval 0.741 to 0.819	0.805 proportion of participants Interval 0.768 to 0.842	0.803 proportion of participants Interval 0.767 to 0.84

SECONDARY outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry

Population: Patients with at least 1 follow-up MUGA scan were included in this analysis.

Cardiac event is defined as left ventricular ejection fraction (LVEF) below the institutional lower limit of normal, where the decrease was >15% absolute percentage points from baseline within 6 months.

Outcome measures

Measure	Arm A (Sunitinib + Sorafenib Placebo) n=513 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.	Arm B (Sorafenib + Sunitinib Placebo) n=510 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.	Arm C (Sunitinib Placebo + Sorafenib Placebo) n=580 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Proportion of Patients With Cardiac Events	0.017 Proportion of participants Interval 0.009 to 0.03	0.013 Proportion of participants Interval 0.006 to 0.026	0.008 Proportion of participants Interval 0.003 to 0.018

SECONDARY outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Population: Patients with clear cell histology were included in this analysis.

Disease-free survival (DFS) is defined as time from randomization to recurrence, development of second primary cancer (except localized breast or prostate cancer or nonmelanoma skin cancer), or death from any cause. Patients who were alive without recurrence or qualifying second primary cancer were censored at the date of last disease evaluation. 5-year DFS rate is the proportion of patients who are alive and disease-free at 5 years based on the Kaplan-Meier estimate.

Outcome measures

Measure	Arm A (Sunitinib + Sorafenib Placebo) n=542 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.	Arm B (Sorafenib + Sunitinib Placebo) n=540 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.	Arm C (Sunitinib Placebo + Sorafenib Placebo) n=540 Participants Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
5-year Disease-free Survival (DFS) Rate Among Patients With Clear Cell Histology	0.534 proportion of participants Interval 0.484 to 0.59	0.527 proportion of participants Interval 0.478 to 0.582	0.560 proportion of participants Interval 0.511 to 0.614

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed every 3 months if patient is < 2 years from study entry; every 6 months if patient is 2 - 5 years from study entry; then annually if patient is 5 - 10 years from study entry

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, 10 weeks and 22 weeks

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at baseline, 10 weeks and 22 weeks

PROMIS Fatigue short form is a newly developed state-of-the-science PROMIS measure for fatigue

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed at 3, 6 and 12 months

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Assessed every 6 weeks while on treatment and for 30 days after the end of treatment

Outcome measures

Outcome data not reported

Adverse Events

Arm A (Sunitinib + Sorafenib Placebo)

Serious events: 368 serious events

Other events: 116 other events

Deaths: 0 deaths

Arm B (Sorafenib + Sunitinib Placebo)

Serious events: 424 serious events

Other events: 117 other events

Deaths: 0 deaths

Arm C (Sunitinib Placebo + Sorafenib Placebo)

Serious events: 81 serious events

Other events: 57 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm A (Sunitinib + Sorafenib Placebo) n=625 participants at risk Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.	Arm B (Sorafenib + Sunitinib Placebo) n=628 participants at risk Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.	Arm C (Sunitinib Placebo + Sorafenib Placebo) n=626 participants at risk Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Immune system disorders Allergic reaction	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Ear and labyrinth disorders Hearing w/o audiogr not in monitor prg	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Blood and lymphatic system disorders Anemia	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Leukocytes decreased	0.48% 3/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Neutrophils decreased	1.1% 7/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Platelets decreased	2.1% 13/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders Heart block abnormality NOS	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders Atrial fibrillation	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders Atrial flutter	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders Sinus bradycardia	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders Supraventricular tachycardia	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Nervous system disorders Vasovagal episode	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders Bigeminy	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders Cardiac-ischemia	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Vascular disorders Hypertension	16.6% 104/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	15.3% 96/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	2.4% 15/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Vascular disorders Hypotension	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders Left ventricular systolic dysfunction	0.64% 4/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders Cor Pulmonale	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders cardiac-other	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
General disorders Fatigue	17.3% 108/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	6.5% 41/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	2.4% 15/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
General disorders Fever w/o neutropenia	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Psychiatric disorders Insomnia	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Weight gain	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Nail changes	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Pruritus/itching	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	1.8% 11/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Rash/desquamation	2.4% 15/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	14.8% 93/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Hand-foot reaction	15.0% 94/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	33.1% 208/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	1.1% 7/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Urticaria	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Injury, poisoning and procedural complications Wound - non-infectious	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Endocrine disorders Adrenal insufficiency	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Endocrine disorders Hyopthyroidism	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Anorexia	1.8% 11/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.80% 5/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Colitis	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Constipation	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Dehydration	1.6% 10/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Diarrhea w/o prior colostomy	9.1% 57/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	8.8% 55/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Distention/bloating, abdominal	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Esophagitis	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Gastritis	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Dyspepsia	2.2% 14/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Ileus	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	0.48% 3/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Respiratory, thoracic and mediastinal disorders Muco/stomatitis (symptom) pharynx	3.8% 24/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	2.2% 14/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Nausea	3.5% 22/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.80% 5/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Perforation, colon	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Vomiting	1.8% 11/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Colon, hemorrhage	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Lower GI, hemorrhage NOS	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Stomach, hemorrhage	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Renal and urinary disorders Kidney, hemorrhage	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Respiratory, thoracic and mediastinal disorders Nose, hemorrhage	0.48% 3/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Hepatobiliary disorders Cholecystitis	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Hepatobiliary disorders Liver dysfunction/failure	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Pancreatitis	0.48% 3/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Hepatobiliary disorders Hepatic-other	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Blood and lymphatic system disorders Febrile neutropenia	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection w/ gr3-4 neut, ileum	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, appendix	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, colon	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, kidney	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, lung	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, mediastinm	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, mucosa	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, muscle	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, nerve-cranial	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, skin	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, urinary tract	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, vagina	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, wound	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection w/ unk ANC skin (cellulitis)	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection w/ unk ANC urinary tract NOS	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection Gr0-2 neut, blood	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Infections and infestations Infection-other	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
General disorders Edema head and neck	0.48% 3/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
General disorders Edema limb	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Hypoalbuminemia	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Alanine aminotransferase increased	0.64% 4/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Serum amylase increased	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Aspartate aminotransferase increased	0.96% 6/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Blood bilirubin increased	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Hypocalcemia	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Hypercholesterolemia	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations CPK increased	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Creatinine increased	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Investigations Lipase increased	0.64% 4/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Hypophosphatemia	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Hyperkalemia	0.48% 3/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Hypokalemia	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Renal and urinary disorders Proteinuria	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Hypernatremia	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Hyponatremia	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.80% 5/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Hypertriglyceridemia	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Metabolism and nutrition disorders Hyperuricemia	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Nonneuropathic upper extr muscle weak	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Nonneuropathic left-side muscle weak	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Nonneuropathic right-side muscle weak	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Myositis	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue-other	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Nervous system disorders Ataxia	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Nervous system disorders CNS cerebrovascular ischemia	0.64% 4/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Nervous system disorders Cognitive disturbance	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Psychiatric disorders Confusion	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Nervous system disorders Dizziness	0.64% 4/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Nervous system disorders Memory impairment	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Psychiatric disorders Anxiety	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Psychiatric disorders Depression	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Nervous system disorders Neuropathy-motor	0.48% 3/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Nervous system disorders Neuropathy-sensory	0.48% 3/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	1.9% 12/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Nervous system disorders Syncope	0.64% 4/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Eye disorders Cataract	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Eye disorders Double vision	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Eye disorders Retinal detachment	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Eye disorders Ocular-other	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Abdomen, pain	0.64% 4/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	1.3% 8/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Back, pain	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Bone, pain	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Cardiac disorders Cardiac/heart, pain	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
General disorders Chest/thoracic pain NOS	0.64% 4/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Esophagus, pain	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Extremity-limb, pain	0.64% 4/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Nervous system disorders Head/headache	0.96% 6/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Joint, pain	1.3% 8/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	1.3% 8/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.48% 3/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Musculoskeletal and connective tissue disorders Muscle, pain	0.32% 2/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	1.3% 8/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Oral cavity, pain	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Scalp, pain	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Skin, pain	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Stomach, pain	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
General disorders Pain-other	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.64% 4/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.32% 2/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Respiratory, thoracic and mediastinal disorders Pleural effusion (non-malignant)	0.16% 1/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Renal and urinary disorders Renal failure	0.96% 6/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.64% 4/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Renal and urinary disorders Renal/GU-other	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Secondary malignancy	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Reproductive system and breast disorders Sexual/Reproductive function-Other	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
General disorders Flu-like syndrome	0.48% 3/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Injury, poisoning and procedural complications Vascular access,Thrombosis/embolism	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Vascular disorders Thrombosis/thrombus/embolism	0.48% 3/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.80% 5/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Vascular disorders Vascular-Other (Specify)	0.00% 0/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.16% 1/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	0.00% 0/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.

Other adverse events

Measure	Arm A (Sunitinib + Sorafenib Placebo) n=625 participants at risk Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.	Arm B (Sorafenib + Sunitinib Placebo) n=628 participants at risk Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.	Arm C (Sunitinib Placebo + Sorafenib Placebo) n=626 participants at risk Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
Vascular disorders Hypertension	6.1% 38/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	6.1% 38/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	1.6% 10/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
General disorders Fatigue	9.9% 62/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	9.2% 58/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	5.0% 31/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Rash/desquamation	2.7% 17/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	6.8% 43/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	2.4% 15/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Skin and subcutaneous tissue disorders Hand-foot reaction	5.8% 36/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	8.3% 52/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	1.1% 7/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Diarrhea w/o prior colostomy	6.6% 41/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	6.4% 40/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	2.1% 13/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.
Gastrointestinal disorders Nausea	5.3% 33/625 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	3.3% 21/628 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.	1.8% 11/626 • Assessed every 6 weeks while on treatment and for 30 days after the end of treatment Only adverse events that are possibly, probably, or definitely related to protocol therapy are reported.

Additional Information

Study Statistician

ECOG-ACRIN Statistical Office

Phone: 617-632-3012

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60