Trial Outcomes & Findings for Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer (NCT NCT01275677)

Last Updated: 2025-07-14

Results Overview

Percentage of patients free from an invasive disease-free survival event where events include any invasive recurrence, contralateral invasive breast cancer, second non-breast primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3270 participants

Primary outcome timeframe

5 years

Results posted on

2025-07-14

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Chemotherapy) GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Chemotherapy, Trastuzumab) GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Overall Study STARTED	1630	1640
Overall Study COMPLETED	1602	1598
Overall Study NOT COMPLETED	28	42

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Chemotherapy) GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Chemotherapy, Trastuzumab) GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Overall Study Not at risk for recurrence.	1	1
Overall Study No follow-up	26	37
Overall Study No clinical follow up.	1	4

Baseline Characteristics

Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I (Chemotherapy) n=1630 Participants Arm I (chemotherapy)	Arm II (Chemotherapy, Trastuzumab) n=1640 Participants Arm II (chemotherapy, trastuzumab)	Total n=3270 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 10.4 • n=5 Participants	52 years STANDARD_DEVIATION 10.4 • n=7 Participants	52 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	1630 Participants n=5 Participants	1640 Participants n=7 Participants	3270 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) Asian	63 Participants n=5 Participants	61 Participants n=7 Participants	124 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	7 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) Black or African American	144 Participants n=5 Participants	175 Participants n=7 Participants	319 Participants n=5 Participants
Race (NIH/OMB) White	1370 Participants n=5 Participants	1354 Participants n=7 Participants	2724 Participants n=5 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants	10 Participants n=7 Participants	19 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	32 Participants n=5 Participants	27 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized Mutually exclusive and exhaustive · Hispanic or Latino	102 Participants n=5 Participants	106 Participants n=7 Participants	208 Participants n=5 Participants
Race/Ethnicity, Customized Mutually exclusive and exhaustive · Not Hispanic or Latino	1488 Participants n=5 Participants	1513 Participants n=7 Participants	3001 Participants n=5 Participants
Race/Ethnicity, Customized Mutually exclusive and exhaustive · Unknown or Not Reported	40 Participants n=5 Participants	21 Participants n=7 Participants	61 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Population: Includes all at-risk patients with clinical follow up

Outcome measures

Outcome measures
Measure	Arm I (Chemotherapy) n=1602 Participants GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Chemotherapy, Trastuzumab) n=1598 Participants GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Percentage of Patients Alive and Free From Invasive Disease (IDFS)	89.2 percentage of patients	89.8 percentage of patients

SECONDARY outcome

Timeframe: 5 years

Population: Includes all at-risk patients with clinical follow-up

Percentage of patients free from a disease-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), second primary cancer (excluding squamous or basal cell carcinoma of the skin), or death from any cause.

Outcome measures

Outcome measures
Measure	Arm I (Chemotherapy) n=1602 Participants GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Chemotherapy, Trastuzumab) n=1598 Participants GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Percentage of Patients Alive and Disease-Free (DFS-DCIS)	89.1 percentage of patients	89.6 percentage of patients

SECONDARY outcome

Timeframe: 5 years

Population: Includes all at-risk patients with clinical follow up

Percentage of patients free from a breast cancer-free survival event where events include local recurrence (invasive or DCIS), regional or distant recurrence, contralateral breast cancer (invasive or DCIS), or death from any cause.

Outcome measures

Outcome measures
Measure	Arm I (Chemotherapy) n=1602 Participants GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Chemotherapy, Trastuzumab) n=1598 Participants GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Percentage of Patients Alive and Free From Breast Cancer (BCFS)	91.0 percentage of patients	90.7 percentage of patients

SECONDARY outcome

Timeframe: 5 years

Population: Includes all at-risk patients with clinical follow-up

Percentage of patients free from a recurrence-free interval event where events include invasive local, regional, or distant recurrence, or death from breast cancer (censored for death from other causes).

Outcome measures

Outcome measures
Measure	Arm I (Chemotherapy) n=1602 Participants GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Chemotherapy, Trastuzumab) n=1598 Participants GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Percentage of Patients Alive and Recurrence-Free (RFI)	92.3 percentage of patients	92.0 percentage of patients

SECONDARY outcome

Timeframe: 5 years

Population: Includes all at-risk patients with clinical follow-up

Percentage of patients free from a distant recurrence-free interval event where events include distant recurrence or death from breast cancer (censored for deaths from other causes), regardless of occurrence of any intervening local or regional recurrences, contralateral breast cancers, or non-breast second primary cancer.

Outcome measures

Outcome measures
Measure	Arm I (Chemotherapy) n=1602 Participants GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Chemotherapy, Trastuzumab) n=1598 Participants GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Percentage of Patients Alive and Free From Distant Recurrence (DRFI)	93.6 percentage of patients	92.7 percentage of patients

SECONDARY outcome

Timeframe: 5 years

Population: Includes all at-risk patients with follow-up

Percentage of patients alive.

Outcome measures

Outcome measures
Measure	Arm I (Chemotherapy) n=1603 Participants GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Chemotherapy, Trastuzumab) n=1602 Participants GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Percentage of Patients Alive (Overall Survival)	96.3 percentage of patients alive	94.8 percentage of patients alive

SECONDARY outcome

Timeframe: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose.

Population: Includes all at-risk patients with clinical follow-up.

Percentage of patients who ever experienced grade 2 or higher toxicites.

Outcome measures

Outcome measures
Measure	Arm I (Chemotherapy) n=1615 Participants GROUP IA: Patients receive docetaxel IV over 60 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 6 cycles in the absence of disease progression or unacceptable toxicity. GROUP IB: Patients receive doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Beginning 2-3 weeks after last dose of doxorubicin hydrochloride and cyclophosphamide, patients also receive paclitaxel IV over 60 minutes once weekly for 12 doses in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies	Arm II (Chemotherapy, Trastuzumab) n=1625 Participants GROUP IIA: Patients receive docetaxel and cyclophosphamide as in Group IA. Patients also receive trastuzumab IV over 30-90 minutes on day 1. Courses repeat every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. GROUP IIB: Patients receive doxorubicin hydrochloride, cyclophosphamide, and paclitaxel as in Group IB. Patients also receive trastuzumab IV over 30-90 minutes weekly for 12 doses and then every 3 weeks for subsequent doses. Treatment repeats every 3 weeks for 1 year in the absence of disease progression or unacceptable toxicity. Cyclophosphamide: Given IV Docetaxel: Given IV Doxorubicin: Given IV Doxorubicin Hydrochloride: Given IV Laboratory Biomarker Analysis: Correlative studies Paclitaxel: Given IV Quality-of-Life Assessment: Ancillary studies Trastuzumab: Given IV
Toxicity Assessed by Adverse Events	90.9 percentage of patients	94.1 percentage of patients

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to up to 24 months

The polymorphism of the Fcgamma 158 receptor gene will be dichotomized as V/V (valine) vs. other genotypes and the polymorphism of the Fcgamma 131 receptor gene will be dichotomized as H/H (histidine) vs. other genotypes to evaluate an interaction between treatment group and Fcgamma polymorphism. The Kaplan-Meier method105 will be used to estimate the distribution of the primary endpoints stratified by the dichotomized subgroups, and the log-rank test106 will be used to statistically compare the time-to-event distributions.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline to 24 months

The interaction between treatment effect and HER2 mRNA level will be evaluated in the proportional hazards model, which would include an indicator for treatment group and the HER2 mRNA level as a continuous variable, and the corresponding interaction term. The log-hazard ratio plot for the interaction term with 95% confidence intervals will be used to determine the cut-off of the HER2 mRNA level that would determine a subset of the patients who would benefit from the adjuvant trastuzumab therapy.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Chemotherapy)

Serious events: 31 serious events

Other events: 1362 other events

Deaths: 48 deaths

Arm II (Chemotherapy, Trastuzumab)

Serious events: 96 serious events

Other events: 1418 other events

Deaths: 61 deaths

Serious adverse events

Other adverse events

Additional Information

Director, Department of Regulatory Affairs

NRG Oncology

Phone: 412-339-5300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60

Serious adverse events
Measure	Arm I (Chemotherapy) n=1615 participants at risk Arm I (chemotherapy)	Arm II (Chemotherapy, Trastuzumab) n=1625 participants at risk Arm II (chemotherapy, trastuzumab)
Respiratory, thoracic and mediastinal disorders Adult respiratory distress syndrome	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Investigations Alanine aminotransferase increased (ALT/SGPT)	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Investigations Aspartate aminotransferase increased (AST/SGOT)	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Cardiac disorders Asystole	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Infections and infestations Catheter related infection	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Gastrointestinal disorders Colonic perforation	0.06% 1/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.00% 0/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Psychiatric disorders Delirium	0.06% 1/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Psychiatric disorders Depression	0.19% 3/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.25% 4/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Gastrointestinal disorders Diarrhea	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Cardiac disorders Heart failure	0.06% 1/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	1.1% 18/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Hepatobiliary disorders Hepatic failure	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Infections and infestations Hepatitis viral	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Metabolism and nutrition disorders Hypercalcemia	0.06% 1/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.00% 0/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Metabolism and nutrition disorders Hyperglycemia	0.12% 2/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.25% 4/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Vascular disorders Hypertension	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.12% 2/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Metabolism and nutrition disorders Hyperuricemia	0.06% 1/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.00% 0/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Metabolism and nutrition disorders Hypocalcemia	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Metabolism and nutrition disorders Hypokalemia	0.12% 2/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.37% 6/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Metabolism and nutrition disorders Hyponatremia	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Vascular disorders Hypotension	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.06% 1/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.00% 0/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Nervous system disorders Intracranial hemorrhage	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Investigations Lipase increased	0.06% 1/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.00% 0/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
General disorders Multi-organ failure	0.06% 1/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.12% 2/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.00% 0/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Cardiac disorders Myocardial infarction	0.12% 2/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.12% 2/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Cardiac disorders Pericardial effusion	0.06% 1/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.00% 0/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.43% 7/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.31% 5/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Pregnancy, puerperium and perinatal conditions Pregnancy, puerperium and perinatal conditions - Other, specify	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.12% 2/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Psychiatric disorders Psychosis	0.00% 0/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.06% 1/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.06% 1/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.00% 0/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Infections and infestations Sepsis	0.12% 2/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	0.43% 7/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).

Other adverse events
Measure	Arm I (Chemotherapy) n=1615 participants at risk Arm I (chemotherapy)	Arm II (Chemotherapy, Trastuzumab) n=1625 participants at risk Arm II (chemotherapy, trastuzumab)
Skin and subcutaneous tissue disorders Alopecia	39.2% 633/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	40.2% 653/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Blood and lymphatic system disorders Anemia	13.7% 222/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	20.1% 327/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Musculoskeletal and connective tissue disorders Arthralgia	10.0% 161/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	14.3% 233/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Musculoskeletal and connective tissue disorders Bone pain	14.1% 228/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	13.6% 221/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Gastrointestinal disorders Constipation	8.4% 135/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	7.6% 124/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Respiratory, thoracic and mediastinal disorders Cough	5.0% 80/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	8.4% 136/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Gastrointestinal disorders Diarrhea	14.1% 228/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	19.9% 324/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
General disorders Fatigue	38.9% 629/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	39.6% 644/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Nervous system disorders Headache	10.2% 164/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	11.5% 187/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Vascular disorders Hypertension	6.4% 103/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	12.1% 196/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Psychiatric disorders Insomnia	6.7% 108/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	7.9% 128/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Investigations Lymphocyte count decreased	8.1% 131/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	9.4% 152/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Gastrointestinal disorders Mucositis oral	14.9% 240/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	14.6% 238/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Musculoskeletal and connective tissue disorders Myalgia	12.1% 196/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	13.7% 222/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Gastrointestinal disorders Nausea	25.3% 408/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	23.2% 377/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Investigations Neutrophil count decreased	9.0% 145/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	10.2% 166/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Nervous system disorders Peripheral sensory neuropathy	17.3% 279/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	19.8% 321/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Infections and infestations Upper respiratory infection	4.8% 78/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	8.2% 133/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Gastrointestinal disorders Vomiting	8.7% 141/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	7.9% 129/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Investigations White blood cell decreased	7.4% 119/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	9.3% 151/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).
Investigations Ejection fraction decreased	0.19% 3/1615 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).	10.1% 164/1625 • All-Cause Mortality: 5 years; Adverse Events: While on study therapy. Day 1 of first dose through 30 days after Day 1 of last dose. B-47 used standard AE reporting based on the descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. The total at-risk patient groups for adverse events reflect the number of patients who had an AE form or an AdEERS report submitted. The at risk group for all-cause mortality reflects the number who submitted an AE form, an AdEERS report, or a follow-up form, (including follow-up by telephone only).