Trial Outcomes & Findings for Erlotinib in Women With Previously Untreated Adenocarcinoma of the Lung (NCT NCT00137839)

Last Updated: 2019-12-17

Results Overview

ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. Stable disease (SD) is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

84 participants

Primary outcome timeframe

In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.

Results posted on

2019-12-17

Participant Flow

Participants were enrolled November 2004 to November 2008.

Participant milestones

Participant milestones
Measure	Erlotinib Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
Overall Study STARTED	84
Overall Study Treated	83
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	84

Reasons for withdrawal

Reasons for withdrawal
Measure	Erlotinib Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
Overall Study Adverse Event	7
Overall Study Physician Decision	7
Overall Study Death	8
Overall Study Disease Progression	60
Overall Study Not Start Treatment	1
Overall Study Prolonged Treatment Delay	1

Baseline Characteristics

One participant was missing date of birth information.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Erlotinib n=84 Participants Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
Age, Continuous	65 years n=83 Participants • One participant was missing date of birth information.
Sex: Female, Male Female	84 Participants n=84 Participants
Sex: Female, Male Male	0 Participants n=84 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=84 Participants
Race (NIH/OMB) Asian	4 Participants n=84 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=84 Participants
Race (NIH/OMB) Black or African American	2 Participants n=84 Participants
Race (NIH/OMB) White	78 Participants n=84 Participants
Race (NIH/OMB) More than one race	0 Participants n=84 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=84 Participants
Region of Enrollment United States	84 participants n=84 Participants
EGFR Status Wild Type	36 Participants n=84 Participants
EGFR Status Mutant	39 Participants n=84 Participants
EGFR Status Unevaluable	9 Participants n=84 Participants

PRIMARY outcome

Timeframe: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.

Population: The analysis dataset is comprised of all treated participants.

Outcome measures

Outcome measures
Measure	Erlotinib n=83 Participants Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.	EGFR Wild Type Mutation status in the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.	Unevaluable EGFR Mutation status in the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.
Overall Response Rate (ORR)	27.7 percentage of participants Interval 18.5 to 38.7	—	—

SECONDARY outcome

Timeframe: In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months.

Population: The analysis dataset is comprised of all treated participants.

ORR is defined as the percentage of participants who achieve partial response (PR) or better on treatment based on RECIST 1.0 criteria: For target lesions, complete response (CR) is disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD (both require a minimum of 4 weeks). Progressive disease (PD) is at least a 20% increase in sum LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started, or appearance of one or more new target lesions. SD is neither PR nor PD. For non-target lesions, PD is the appearance of one or more new non-target lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Erlotinib n=39 Participants Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.	EGFR Wild Type n=35 Participants Mutation status in the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.	Unevaluable EGFR n=9 Participants Mutation status in the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.
Overall Response Rate (ORR) by EGFR Mutation Status	56.4 percentage of participants Interval 39.6 to 72.2	2.9 percentage of participants Interval 0.1 to 12.8	0.0 percentage of participants Interval 0.0 to 33.6

SECONDARY outcome

Timeframe: In this study cohort, participants were followed for survival up to 155 months.

Population: The analysis dataset is comprised of all enrolled participants.

OS is defined as the time from study entry to death or date last known alive.

Outcome measures

Outcome measures
Measure	Erlotinib n=84 Participants Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.	EGFR Wild Type Mutation status in the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.	Unevaluable EGFR Mutation status in the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.
Overall Survival (OS)	22.9 months Interval 15.7 to 26.5	—	—

SECONDARY outcome

Timeframe: In this study cohort, participants were followed for survival up to 155 months.

Population: The analysis dataset is comprised of all treated participants.

OS is defined as the time from study entry to death or date last known alive.

Outcome measures

Outcome measures
Measure	Erlotinib n=39 Participants Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.	EGFR Wild Type n=36 Participants Mutation status in the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.	Unevaluable EGFR n=9 Participants Mutation status in the epidermal growth factor receptor (EGFR) gene in tumor specimens was determined by standard methods of immunohistochemistry.
Overall Survival by EGFR Mutation Status	32.6 months Interval 24.4 to 44.0	9.9 months Interval 6.6 to 16.2	15.7 months Interval 1.4 to 109.6

Adverse Events

Erlotinib

Serious events: 33 serious events

Other events: 83 other events

Deaths: 83 deaths

Serious adverse events

Serious adverse events
Measure	Erlotinib n=83 participants at risk Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
Gastrointestinal disorders Diarrhea w/o prior colostomy	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Hemorrhoids	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Nausea	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Fatigue	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Extremity-lower (gait/walking)	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Hepatobiliary disorders Liver dysfunction/failure	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, eye NOS	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, oral cavity	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, skin	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations INR	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations PTT	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations ALT, SGPT	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations AST, SGOT	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Bilirubin	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Creatinine	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Anorexia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Dehydration	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypoalbuminemia	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypoglycemia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hyperkalemia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hyponatremia	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Muco/stomatitis (symptom) pharynx	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Dry skin	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Rash/desquamation	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	16.9% 14/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Skin-other	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Vascular disorders Thrombosis/thrombus/embolism	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.

Other adverse events

Other adverse events
Measure	Erlotinib n=83 participants at risk Erlotinib: 150 mg orally once daily without interruption Cycle duration considered 4 weeks and treatment duration indefinite until disease progression, unacceptable toxicity or withdrawal for other reasons.
Investigations Death - disease progression NOS	1.2% 1/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Blood and lymphatic system disorders Hemoglobin	14.5% 12/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Blood and lymphatic system disorders Hematologic-other	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Blood and lymphatic system disorders DIC	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Cardiac disorders Palpitations	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Cardiac disorders Atrial fibrillation	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Cardiac disorders Sinus tachycardia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Cardiac disorders Arrhythmia-other	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Cardiac disorders C-P arrest, non-fatal, cause unknown	1.2% 1/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Cardiac disorders Left ventricular systolic dysfunction	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Cardiac disorders Valvular heart disease	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Cardiac disorders Cardiac-other	8.4% 7/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Ear and labyrinth disorders External ear, pain	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Endocrine disorders Hyopthyroidism	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Eye disorders Dry eye syndrome	18.1% 15/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Eye disorders Ocular surface disease	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Eye disorders Vision-blurred	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Eye disorders Tearing	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Eye disorders Ocular-other	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Eye disorders Eye, pain	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Constipation	13.3% 11/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Dentures or dental prosthesis	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Diarrhea w/o prior colostomy	74.7% 62/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Dry mouth	9.6% 8/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Dysphagia	8.4% 7/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Flatulence	2.4% 2/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Gastritis	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Dyspepsia	12.0% 10/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Hemorrhoids	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Muco/stomatitis by exam, oral cavity	15.7% 13/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Muco/stomatitis (symptom) oral cavity	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Nausea	31.3% 26/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Proctitis	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Vomiting	15.7% 13/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders GI-other	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Anus, hemorrhage	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Lower GI, hemorrhage NOS	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Rectum, hemorrhage	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Upper GI, hemorrhage NOS	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Pancreatitis	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Abdomen, pain	7.2% 6/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Oral cavity, pain	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Gastrointestinal disorders Oral gums, pain	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Fatigue	39.8% 33/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Fever w/o neutropenia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Rigors/chills	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Constitutional, other	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Death - multiorgan failure	1.2% 1/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Death - sudden death	1.2% 1/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Edema limb	7.2% 6/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Extremity-lower (gait/walking)	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Chest/thoracic pain NOS	14.5% 12/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Pain NOS	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
General disorders Pain-other	7.2% 6/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Hepatobiliary disorders Liver dysfunction/failure	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Immune system disorders Allergic reaction	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ gr3-4 neut, wound	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, external ear	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, eye NOS	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, lip/perioral	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, lung	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, nerve-periph	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, oral cavity	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, skin	7.2% 6/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, stomach	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, ungual	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, upper airway	8.4% 7/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, urinary tract	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, vagina	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr0-2 neut, wound	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC conjunctiva	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC dental-tooth	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC lymphatic	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC middle ear	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC nose	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC oral cavity/gums	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC pharynx	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC skin (cellulitis)	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC ungual (nails)	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC upper airway NOS	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC urinary tract NOS	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC vagina	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection w/ unk ANC wound	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection Gr 0-2 neut, blood	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Infections and infestations Infection-other	7.2% 6/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Injury, poisoning and procedural complications Bruising	2.4% 2/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Injury, poisoning and procedural complications Burn	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Injury, poisoning and procedural complications Fracture	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Leukocytes	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Neutrophils	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Platelets	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Weight loss	10.8% 9/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations INR	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations PTT	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Coagulation-other	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Alkaline phosphatase	9.6% 8/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations ALT, SGPT	13.3% 11/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations AST, SGOT	14.5% 12/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Bilirubin	22.9% 19/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Creatinine	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Investigations Metabolic/Laboratory-other	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Anorexia	27.7% 23/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Dehydration	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypoalbuminemia	13.3% 11/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypercalcemia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypocalcemia	9.6% 8/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hyperglycemia	18.1% 15/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypoglycemia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypermagnesemia	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypomagnesemia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypophosphatemia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hyperkalemia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypokalemia	8.4% 7/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hyponatremia	14.5% 12/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Metabolism and nutrition disorders Hypertriglyceridemia	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Arthritis	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Nonneuropathic lower extr muscle weak	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Nonneuropathic generalized weakness	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Musculoskeletal/soft tissue-other	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Back, pain	7.2% 6/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Bone, pain	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Chest wall, pain	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Extremity-limb, pain	10.8% 9/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Joint, pain	8.4% 7/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Muscle, pain	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Musculoskeletal and connective tissue disorders Neck, pain	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Taste disturbance	19.3% 16/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Cognitive disturbance	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Dizziness	13.3% 11/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Encephalopathy	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Memory impairment	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Neuropathy CN VII face-motor / taste	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Neuropathy-sensory	8.4% 7/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Depressed level of consciousness	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Syncope	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Tremor	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Neurologic-other	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Ocular-other	13.3% 11/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Nervous system disorders Head/headache	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Psychiatric disorders Insomnia	10.8% 9/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Psychiatric disorders Confusion	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Psychiatric disorders Anxiety	12.0% 10/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Psychiatric disorders Depression	7.2% 6/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Renal and urinary disorders Proteinuria	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Renal and urinary disorders Obstruction-urethra	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Renal and urinary disorders Renal failure	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Renal and urinary disorders Urinary frequency/urgency	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Renal and urinary disorders Renal/GU-other	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Reproductive system and breast disorders Breast, pain	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Reproductive system and breast disorders Vaginal dryness	2.4% 2/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Muco/stomatitis by exam, pharynx	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Muco/stomatitis (symptom) pharynx	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Lung, hemorrhage	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Nose, hemorrhage	9.6% 8/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Apnea	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Throat/pharynx/larynx, pain	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Bronchospasm, wheezing	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Cough	33.7% 28/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Dyspnea	22.9% 19/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Hypoxia	7.2% 6/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Nasal cavity/paranasal sinus reaction	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Pneumothorax	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Voice changes/dysarthria	8.4% 7/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Respiratory, thoracic and mediastinal disorders Pulmonary/Upper Respiratory-other	8.4% 7/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Sweating	2.4% 2/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Dry skin	56.6% 47/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Alopecia	25.3% 21/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Hyperpigmentation	2.4% 2/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Induration/fibrosis	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Nail changes	20.5% 17/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Photosensitivity	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Pruritus/itching	27.7% 23/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Rash/desquamation	12.0% 10/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Rash: acne/acneiform	79.5% 66/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Erythema multiforme	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Hand-foot reaction	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Skin breakdown/decubitus ulcer	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Ulceration	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Skin and subcutaneous tissue disorders Skin-other	43.4% 36/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Vascular disorders Hypertension	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Vascular disorders Hypotension	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Vascular disorders Hot flashes	3.6% 3/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Vascular disorders Hematoma	6.0% 5/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Vascular disorders Hemorrhage-other	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.
Vascular disorders Thrombosis/thrombus/embolism	4.8% 4/83 • Adverse events (AEs) based on the National Cancer Institute's Common Toxicity Criteria for Adverse Events version 3 (CTCAEv3) were assessed every 4 weeks on treatment. In this study cohort, treatment duration which parallels the maximum observation time was up to 39 months. Maximum grade toxicity by type was first calculated. Serious AEs were defined as events with treatment-attribution of possibly, probably or definitely and grade 3 or higher per CTCAEv3. All remaining events regardless of treatment attribution were classified as Other AEs. No further data is available to specify classification of other beyond the general term.The analysis dataset for AEs is comprised of all treated participants versus all enrolled for all cause mortality/any death on study.

Additional Information

David Jackman, MD

Dana-Farber Cancer Institute

Phone: 617-632-6049

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place