Trial Outcomes & Findings for Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy (NCT NCT00769379)

Last Updated: 2025-06-12

Results Overview

Patients who are free from Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence or Ipsilateral DCIS as estimated by (1- cumulative incidence) x 100%.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2014 participants

Primary outcome timeframe

5 years

Results posted on

2025-06-12

Participant Flow

Participant milestones

Participant milestones
Measure	Arm I (Standard WBI) Patients undergo standard WBI over 5-6 weeks. Laboratory Biomarker Analysis: Correlative studies Whole Breast Irradiation: Undergo standard whole breast irradiation	Arm II (WBI, Trastuzumab) Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. Laboratory Biomarker Analysis: Correlative studies Trastuzumab: Given IV Whole Breast Irradiation: Undergo standard whole breast irradiation
Overall Study STARTED	1008	1006
Overall Study COMPLETED	1005	993
Overall Study NOT COMPLETED	3	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm I (Standard WBI) Patients undergo standard WBI over 5-6 weeks. Laboratory Biomarker Analysis: Correlative studies Whole Breast Irradiation: Undergo standard whole breast irradiation	Arm II (WBI, Trastuzumab) Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. Laboratory Biomarker Analysis: Correlative studies Trastuzumab: Given IV Whole Breast Irradiation: Undergo standard whole breast irradiation
Overall Study No follow up data mapped to Other.	3	13

Baseline Characteristics

Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard WBI n=1008 Participants Standard WBI (Radiation Therapy)	WBI, Trastuzumab n=1006 Participants WBI, trastuzumab (Radiation Therapy + Trastuzumab x 2 doses. Dose 1: 8 mg/kg IV Dose 2: 6 mg/kg IV-given 3 weeks after dose 1	Total n=2014 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 9.3 • n=5 Participants	56 years STANDARD_DEVIATION 8.7 • n=7 Participants	56 years STANDARD_DEVIATION 9.0 • n=5 Participants
Sex: Female, Male Female	1008 Participants n=5 Participants	1006 Participants n=7 Participants	2014 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	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Asian	33 Participants n=5 Participants	43 Participants n=7 Participants	76 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) Black or African American	59 Participants n=5 Participants	58 Participants n=7 Participants	117 Participants n=5 Participants
Race (NIH/OMB) White	893 Participants n=5 Participants	885 Participants n=7 Participants	1778 Participants n=5 Participants
Race (NIH/OMB) More than one race	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Latino	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Race/Ethnicity, Customized Non-Latino	925 Participants n=5 Participants	920 Participants n=7 Participants	1845 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants

PRIMARY outcome

Timeframe: 5 years

Patients who are free from Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence or Ipsilateral DCIS as estimated by (1- cumulative incidence) x 100%.

Outcome measures

Outcome measures
Measure	Arm I (Standard WBI) n=1005 Participants Patients undergo standard WBI over 5-6 weeks. Laboratory Biomarker Analysis: Correlative studies Whole Breast Irradiation: Undergo standard whole breast irradiation	Arm II (WBI, Trastuzumab) n=993 Participants Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. Laboratory Biomarker Analysis: Correlative studies Trastuzumab: Given IV Whole Breast Irradiation: Undergo standard whole breast irradiation
Ipsilateral Invasive Breast Cancer, Ipsilateral Skin Cancer Recurrence, or Ipsilateral DCIS-Free Survival	95.1 percentage of patients event free Interval 93.8 to 96.5	96.1 percentage of patients event free Interval 94.9 to 97.3

SECONDARY outcome

Timeframe: 5 years

Events for analysis of IDFS-DCIS include: local recurrence in the ipsilateral breast following lumpectomy, regional recurrence, distant recurrence, contralateral breast cancer, second primary cancer (other than squamous and basal cell carcinoma of the skin, melanoma in situ, and carcinoma in situ of the colon and cervix), or death from any cause prior to recurrence or second primary cancer. Invasive breast cancer, ipsilateral recurrence, and contralateral breast cancer will be compared across treatment arms using cumulative incidence functions. Percentage of patients by a Kaplan-Meier analysis who are free of invasive or DCIS disease

Outcome measures

Outcome measures
Measure	Arm I (Standard WBI) n=1005 Participants Patients undergo standard WBI over 5-6 weeks. Laboratory Biomarker Analysis: Correlative studies Whole Breast Irradiation: Undergo standard whole breast irradiation	Arm II (WBI, Trastuzumab) n=993 Participants Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. Laboratory Biomarker Analysis: Correlative studies Trastuzumab: Given IV Whole Breast Irradiation: Undergo standard whole breast irradiation
Invasive or DCIS Disease-free Survival	88.4 percentage of patients event free Interval 86.3 to 90.4	90.6 percentage of patients event free Interval 88.8 to 92.5

SECONDARY outcome

Timeframe: 5 years

Cox proportional hazards models will be used to evaluate the effect of treatment on time to event. The distributions of time to event will be estimated by the Kaplan-Meier method for each treatment group and will be compared between treatments by simple and stratified log-rank tests. Compared across treatment arms using cumulative incidence functions.Percentage of patients who are invasive or DCIS recurrence free estimated by (1-cumulative incidence) x 100%.

Outcome measures

Outcome measures
Measure	Arm I (Standard WBI) n=1005 Participants Patients undergo standard WBI over 5-6 weeks. Laboratory Biomarker Analysis: Correlative studies Whole Breast Irradiation: Undergo standard whole breast irradiation	Arm II (WBI, Trastuzumab) n=993 Participants Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. Laboratory Biomarker Analysis: Correlative studies Trastuzumab: Given IV Whole Breast Irradiation: Undergo standard whole breast irradiation
Invasive or DCIS Recurrence-free Interval	94.4 percentage of patients event free Interval 92.9 to 95.8	95.8 percentage of patients event free Interval 94.5 to 97.1

SECONDARY outcome

Timeframe: 5 years

Percentage of patients who are free of invasive regional or distant recurrence as estimated by (1 - cumulative incidence) x 100%.

Outcome measures

Outcome measures
Measure	Arm I (Standard WBI) n=1005 Participants Patients undergo standard WBI over 5-6 weeks. Laboratory Biomarker Analysis: Correlative studies Whole Breast Irradiation: Undergo standard whole breast irradiation	Arm II (WBI, Trastuzumab) n=993 Participants Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. Laboratory Biomarker Analysis: Correlative studies Trastuzumab: Given IV Whole Breast Irradiation: Undergo standard whole breast irradiation
Invasive Regional or Distant-Free Recurrence	99.9 percentage of patients event free Interval 99.7 to 100.0	99.9 percentage of patients event free Interval 99.7 to 100.0

SECONDARY outcome

Timeframe: 5 years

Percentage of patients free of Contralateral Breast Cancer (Invasive or DCIS) as estimated by (1- cumulative incidence) x 100%.

Outcome measures

Outcome measures
Measure	Arm I (Standard WBI) n=1005 Participants Patients undergo standard WBI over 5-6 weeks. Laboratory Biomarker Analysis: Correlative studies Whole Breast Irradiation: Undergo standard whole breast irradiation	Arm II (WBI, Trastuzumab) n=993 Participants Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. Laboratory Biomarker Analysis: Correlative studies Trastuzumab: Given IV Whole Breast Irradiation: Undergo standard whole breast irradiation
Contralateral Breast Cancer (Invasive or DCIS) - Free Survival	97.9 percentage of patients event free Interval 97.0 to 98.8	98.4 percentage of patients event free Interval 97.6 to 99.2

SECONDARY outcome

Timeframe: 5 years

Percentage of patients surviving as estimated by a Kaplan-Meier

Outcome measures

Outcome measures
Measure	Arm I (Standard WBI) n=1005 Participants Patients undergo standard WBI over 5-6 weeks. Laboratory Biomarker Analysis: Correlative studies Whole Breast Irradiation: Undergo standard whole breast irradiation	Arm II (WBI, Trastuzumab) n=993 Participants Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. Laboratory Biomarker Analysis: Correlative studies Trastuzumab: Given IV Whole Breast Irradiation: Undergo standard whole breast irradiation
Overall Survival	98.9 percentage of patients surviving Interval 98.2 to 99.5	99.0 percentage of patients surviving Interval 98.3 to 99.6

SECONDARY outcome

Timeframe: 18 months

Population: All patients who reported being postmenopausal at randomization who later self-reported as yes or no to whether or not they had menstrual periods.

Proportion of patients who were pre-menopausal at randomization and who self-reported as not having menstrual periods afterwards

Outcome measures

Outcome measures
Measure	Arm I (Standard WBI) n=126 Participants Patients undergo standard WBI over 5-6 weeks. Laboratory Biomarker Analysis: Correlative studies Whole Breast Irradiation: Undergo standard whole breast irradiation	Arm II (WBI, Trastuzumab) n=121 Participants Patients receive trastuzumab IV over 30-90 minutes once in weeks 1 and 4. Patients also undergo WBI as in Arm I. Laboratory Biomarker Analysis: Correlative studies Trastuzumab: Given IV Whole Breast Irradiation: Undergo standard whole breast irradiation
Incidence of Post-treatment Amenorrhea in Women Who Were Premenopausal at the Time of Study Entry Premenopausal at the Time of Study Entry	63 percentage of participants	72 percentage of participants

Adverse Events

Standard WBI

Serious events: 3 serious events

Other events: 292 other events

Deaths: 11 deaths

WBI, Trastuzumab

Serious events: 9 serious events

Other events: 254 other events

Deaths: 10 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Standard WBI n=998 participants at risk standard WBI	WBI, Trastuzumab n=990 participants at risk WBI, trastuzumab
General disorders Fatigue	8.0% 80/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	7.8% 77/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Injury, poisoning and procedural complications Dermatitis radiation	26.2% 261/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	21.0% 208/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.

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

Measure	Standard WBI n=998 participants at risk standard WBI	WBI, Trastuzumab n=990 participants at risk WBI, trastuzumab
Cardiac disorders Atrial flutter	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Investigations Cardiac troponin I increased	0.10% 1/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.00% 0/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Hepatobiliary disorders Cholecystitis	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Metabolism and nutrition disorders Dehydration	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Vascular disorders Hypotension	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Cardiac disorders Myocardial infarction	0.10% 1/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.00% 0/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Vascular disorders Thromboembolic event	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Infections and infestations Urinary tract infection	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Ear and labyrinth disorders Vertigo	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia secondary to oncology chemotherapy	0.10% 1/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.00% 0/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.20% 2/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.
Infections and infestations Lung infection	0.00% 0/998 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.	0.10% 1/990 • All Cause Mortality-5 years: Adverse Events: While on study therapy, Day 1 of 1st dose through 30 days after Day 1 of last dose. All Cause mortality at 5-years is the proportion of all patients with follow-up information who have died within the first 5 years after randomization. Adverse event proportions only include patients who had reported AE forms during the period of 30 days after their 1st last dose of protocol therapy.