Trial Outcomes & Findings for Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer (NCT NCT00087178)

Last Updated: 2022-08-11

Results Overview

Percentage of patients free from DFS event. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2722 participants

Primary outcome timeframe

9 years

Results posted on

2022-08-11

Participant Flow

Participant milestones

Participant milestones
Measure	Arm 1: Adriamycin + Cyclophosphamide Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Overall Study STARTED	1361	1361
Overall Study COMPLETED	1355	1343
Overall Study NOT COMPLETED	6	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm 1: Adriamycin + Cyclophosphamide Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Overall Study No follow up data	5	15
Overall Study No clinical assessment	1	2
Overall Study Patient not at risk for primary endpoint	0	1

Baseline Characteristics

Comparison of Two Combination Chemotherapy Regimens in Treating Women With Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1- Adriamycin + Cyclophosphamide n=1361 Participants Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1:cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2 - Fluorouracil + Epirubicin + Cyclophosphamide n=1361 Participants Patients receive fluorouracil IV, epirubican IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles	Total n=2722 Participants Total of all reporting groups
Age, Continuous	52 years STANDARD_DEVIATION 9.4 • n=5 Participants	52 years STANDARD_DEVIATION 9.6 • n=7 Participants	52 years STANDARD_DEVIATION 9.5 • n=5 Participants
Sex: Female, Male Female	1361 Participants n=5 Participants	1361 Participants n=7 Participants	2722 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 9 years

Percentage of patients free from DFS event. DFS events include local, regional, or distant recurrence, second primary cancer or death from any cause prior to recurrence or second primary cancer

Outcome measures

Outcome measures
Measure	Arm 1: Adriamycin + Cyclophosphamide n=1355 Participants Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide n=1343 Participants Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Disease Free Survival	80.1 percentage of participants	79.4 percentage of participants

SECONDARY outcome

Timeframe: 9 years

Population: Patients with any type of follow-up.

Percentage of patients alive

Outcome measures

Outcome measures
Measure	Arm 1: Adriamycin + Cyclophosphamide n=1356 Participants Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide n=1345 Participants Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Survival	89.8 percentage of participants alive	89.9 percentage of participants alive

SECONDARY outcome

Timeframe: 9 years

Population: Patients with follow-up and available adverse event information.

Percentage of patients with at least one grade 2 or higher adverse event reported

Outcome measures

Outcome measures
Measure	Arm 1: Adriamycin + Cyclophosphamide n=1349 Participants Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide n=1333 Participants Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Adverse Events	28.5 percentage of participants	45.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Patients who participated in the QOL sub-study

Functional Assessment of Cancer Therapy (FACT-B) trial outcome index (TOI) score. FACT-B TOI score ranges from 0 to 92, with a higher score indicating better QOL.

Outcome measures

Outcome measures
Measure	Arm 1: Adriamycin + Cyclophosphamide n=675 Participants Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide n=656 Participants Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Quality of Life-Functional Assessment of Cancer Therapy Score day 1 cycle 4	61.7 score on a scale Interval 60.9 to 62.7	60.3 score on a scale Interval 59.4 to 61.2
Quality of Life-Functional Assessment of Cancer Therapy Score 6 months	69.2 score on a scale Interval 68.3 to 70.1	66.9 score on a scale Interval 66.0 to 67.8
Quality of Life-Functional Assessment of Cancer Therapy Score 12 months	71.7 score on a scale Interval 70.8 to 72.7	71.1 score on a scale Interval 70.2 to 72.0

SECONDARY outcome

Timeframe: 18 months

Population: Patients who participated in the Menstrual History sub-study

Percent with post chemotherapy amenorrhea

Outcome measures

Outcome measures
Measure	Arm 1: Adriamycin + Cyclophosphamide n=474 Participants Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide n=451 Participants Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Post Chemotherapy Amenorrhea	59.1 percentage of participants	67.4 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Population: Patients who participated in the cardiac function sub-study

Change in LVEF from randomization to 12 months

Outcome measures

Outcome measures
Measure	Arm 1: Adriamycin + Cyclophosphamide n=159 Participants Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide n=146 Participants Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Change in Left Ventricular Ejection Fraction (LVEF) at the 12-month Evaluation	-2.61 Change in percent ejection fraction Interval -3.7 to -1.53	-2.65 Change in percent ejection fraction Interval -3.79 to -1.52

SECONDARY outcome

Timeframe: 6 years

Population: Data were not collected. Gene amplification analysis was not performed on the submitted blocks.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 years

Percentage of patients with local-regional recurrence or distant recurrence

Outcome measures

Outcome measures
Measure	Arm 1: Adriamycin + Cyclophosphamide n=1355 Participants Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide n=1343 Participants Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Recurrence-free Interval	10.8 percentage of participants	10.4 percentage of participants

SECONDARY outcome

Timeframe: 9 years

Percentage of patients with distant recurrence

Outcome measures

Outcome measures
Measure	Arm 1: Adriamycin + Cyclophosphamide n=1355 Participants Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Arm 2: Fluorouracil + Epirubicin + Cyclophosphamide n=1343 Participants Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Distant Recurrence-free Interval	8.3 percentage of participants	7.2 percentage of participants

Adverse Events

Adriamycin + Cyclophosphamide

Serious events: 12 serious events

Other events: 290 other events

Deaths: 0 deaths

Fluorouracil + Epirubicin + Cyclophosphamide

Serious events: 26 serious events

Other events: 454 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Adriamycin + Cyclophosphamide n=1351 participants at risk Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Fluorouracil + Epirubicin + Cyclophosphamide n=1337 participants at risk Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Blood and lymphatic system disorders Anemia	7.8% 106/1351 Participants at Risk includes any patient who submitted an AE form.	11.0% 147/1337 Participants at Risk includes any patient who submitted an AE form.
General disorders Fatigue	8.7% 118/1351 Participants at Risk includes any patient who submitted an AE form.	12.3% 165/1337 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Febrile neutropenia	3.7% 50/1351 Participants at Risk includes any patient who submitted an AE form.	9.5% 127/1337 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Mucositis oral	3.1% 42/1351 Participants at Risk includes any patient who submitted an AE form.	6.1% 81/1337 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Nausea	7.0% 94/1351 Participants at Risk includes any patient who submitted an AE form.	9.1% 121/1337 Participants at Risk includes any patient who submitted an AE form.
Investigations Neutrophil count decreased	5.9% 80/1351 Participants at Risk includes any patient who submitted an AE form.	6.9% 92/1337 Participants at Risk includes any patient who submitted an AE form.
Investigations Platelet count decreased	1.9% 25/1351 Participants at Risk includes any patient who submitted an AE form.	6.3% 84/1337 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Vomiting	4.6% 62/1351 Participants at Risk includes any patient who submitted an AE form.	7.4% 99/1337 Participants at Risk includes any patient who submitted an AE form.

Additional Information

Director, Department of Regulatory Affairs

NRG Oncololgy

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	Adriamycin + Cyclophosphamide n=1351 participants at risk Patients receive adriamycin IV over 15 minutes followed by cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles adriamycin: adriamycin 60 mg/m2 IV every 21 days for 4 cycles	Fluorouracil + Epirubicin + Cyclophosphamide n=1337 participants at risk Patients receive fluorouracil IV, epirubicin IV over 15 minutes, and cyclophosphamide IV over 30 minutes on day 1. Treatment repeats every 21 days for 6 courses. cyclophosphamide: Arm 1: cyclophosphamide 600 mg/m2 IV every 21 days for 4 cycles; Arm 2: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles epirubicin: epirubicin 100 mg/m2 IV every 21 days for 6 cycles fluorouracil: fluorouracil 500 mg/m2 IV every 21 days for 6 cycles
Psychiatric disorders Agitation	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1337 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Anemia	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Anxiety	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Atrial fibrillation	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Colonic perforation	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Psychiatric disorders Depression	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Diarrhea	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1337 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Heart failure	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hyperkalemia	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.15% 2/1337 Participants at Risk includes any patient who submitted an AE form.
Metabolism and nutrition disorders Hypocalcemia	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1337 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Infections and infestations - Other, specify	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Mucositis oral	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Nausea	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Investigations Neutrophil count decreased	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.15% 2/1337 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Pericardial effusion	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Pericarditis	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Investigations Platelet count decreased	0.22% 3/1351 Participants at Risk includes any patient who submitted an AE form.	0.30% 4/1337 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Stroke	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.15% 2/1337 Participants at Risk includes any patient who submitted an AE form.
General disorders Sudden death NOS	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.15% 2/1337 Participants at Risk includes any patient who submitted an AE form.
Nervous system disorders Syncope	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Vascular disorders Thromboembolic event	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.30% 4/1337 Participants at Risk includes any patient who submitted an AE form.
Reproductive system and breast disorders Uterine hemorrhage	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Gastrointestinal disorders Vomiting	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukemia secondary to oncology chemotherapy	0.22% 3/1351 Participants at Risk includes any patient who submitted an AE form.	0.15% 2/1337 Participants at Risk includes any patient who submitted an AE form.
Investigations White blood cell decreased	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Treatment related secondary malignancy	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.15% 2/1337 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Enterocolitis infectious	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1337 Participants at Risk includes any patient who submitted an AE form.
Infections and infestations Mucosal infection	0.07% 1/1351 Participants at Risk includes any patient who submitted an AE form.	0.00% 0/1337 Participants at Risk includes any patient who submitted an AE form.
Renal and urinary disorders Acute kidney injury	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.07% 1/1337 Participants at Risk includes any patient who submitted an AE form.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/1351 Participants at Risk includes any patient who submitted an AE form.	0.15% 2/1337 Participants at Risk includes any patient who submitted an AE form.