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Trial Outcomes & Findings for Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer (NCT NCT00041119)

NCT ID: NCT00041119

Last Updated: 2017-05-18

Results Overview

To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for relapse-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

3871 participants

Primary outcome timeframe

from baseline up to 4 years

Results posted on

2017-05-18

Participant Flow

Participant milestones

Participant milestones
Measure
Arm I (CA for 4 Courses)
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm III (Paclitaxel for 4 Courses)
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Study
STARTED
1142
789
1151
789
Overall Study
COMPLETED
1142
789
1151
789
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Four Versus Six Cycles of Cyclophosphamide/Doxorubicin or Paclitaxel in Adjuvant Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Arm I (CA for 4 Courses)
n=1142 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])
n=789 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm III (Paclitaxel for 4 Courses)
n=1151 Participants
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])
n=789 Participants
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Total
n=3871 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
Age, Categorical
Between 18 and 65 years
978 Participants
n=5 Participants
719 Participants
n=7 Participants
987 Participants
n=5 Participants
715 Participants
n=4 Participants
3399 Participants
n=21 Participants
Age, Categorical
>=65 years
164 Participants
n=5 Participants
70 Participants
n=7 Participants
164 Participants
n=5 Participants
74 Participants
n=4 Participants
472 Participants
n=21 Participants
Age, Continuous
53.7 years
STANDARD_DEVIATION 9.9 • n=5 Participants
52.6 years
STANDARD_DEVIATION 9.1 • n=7 Participants
54.0 years
STANDARD_DEVIATION 9.9 • n=5 Participants
52.7 years
STANDARD_DEVIATION 9.2 • n=4 Participants
53.4 years
STANDARD_DEVIATION 9.6 • n=21 Participants
Sex: Female, Male
Female
1142 Participants
n=5 Participants
789 Participants
n=7 Participants
1151 Participants
n=5 Participants
789 Participants
n=4 Participants
3871 Participants
n=21 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants

PRIMARY outcome

Timeframe: from baseline up to 4 years

Population: All patients that were eligible and received treatment were analyzed. 700 patients were not included due to the timing that the analysis was performed.

To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for relapse-free survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together.

Outcome measures

Outcome measures
Measure
4 Cycles (Arm I and Arm III Combined)
n=1593 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
6 Cycles (Arm II and Arm IV Combined)
n=1578 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Relapse Free Survival (RFS) 4 vs. 6 Cycles
NA years
The median has not been reached
NA years
The median has not been reached

PRIMARY outcome

Timeframe: from baseline up to 6.4 years

Population: All eligible patients were treated and analyzed.

To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for disease-free survival. Objective progression is defined as the appearance of local (chest wall, axillary, supraclavicular nodes) or distant metastases. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis.

Outcome measures

Outcome measures
Measure
4 Cycles (Arm I and Arm III Combined)
n=1931 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
6 Cycles (Arm II and Arm IV Combined)
n=1940 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Duration of Disease Free Survival (RFS)
NA months
The median for disease free survival was never reached
NA months
The median for disease free survival was never reached

SECONDARY outcome

Timeframe: from baseline up to 5 years

Population: All patients that were eligible and treated for the study were evaluated.

To determine the equivalence of paclitaxel to CA as adjuvant therapy for women with 0-3 positive axillary lymph nodes, for overall survival. OS will be measured from study entry until death due to any cause. Survivors will be censored at the date of last follow-up.. The trial is designed to show the equivalence of the experimental agent T with the standard agent combination CA, thus the 4 and 6 course arms of each drug will be combined to conduct this analysis.

Outcome measures

Outcome measures
Measure
4 Cycles (Arm I and Arm III Combined)
n=1931 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
6 Cycles (Arm II and Arm IV Combined)
n=1940 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS)
95 percentage of participants at 5 years
94 percentage of participants at 5 years

SECONDARY outcome

Timeframe: from baseline up to 6 weeks post-treatment

Population: 3754 patients were considered evaluable for toxicity that occurred during treatment.

To compare toxicities of short course CA and paclitaxel with long course CA and paclitaxel as adjuvant therapy for women with 0-3 positive axillary lymph node breast cancer. The percentage of patients that received a grade 3 or higher hematologic event will be reported here. We will be combining arm I with arm III, as well as arm II with arm IV. For a complete list of adverse events, please refer to the adverse events section.

Outcome measures

Outcome measures
Measure
4 Cycles (Arm I and Arm III Combined)
n=1528 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
6 Cycles (Arm II and Arm IV Combined)
n=2226 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Adverse Events
38 percentage of patients
29 percentage of patients

SECONDARY outcome

Timeframe: from baseline up to 15 years

Population: All patients that were eligible and received treatment were analyzed.

Local control and distant metastasis will be calculated as the cumulative incidence of first local relapse and first distant metastasis, respectively.

Outcome measures

Outcome measures
Measure
4 Cycles (Arm I and Arm III Combined)
n=1931 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
6 Cycles (Arm II and Arm IV Combined)
n=1940 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Time to Distant Metastases
NA years
The median has not been reached
NA years
The median has not been reached

SECONDARY outcome

Timeframe: from baseline up to 15 years

Population: All patients that were eligible and received treatment were analyzed.

Local control will be calculated as the cumulative incidence of first local relapse.

Outcome measures

Outcome measures
Measure
4 Cycles (Arm I and Arm III Combined)
n=1931 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
6 Cycles (Arm II and Arm IV Combined)
n=1940 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Local Control
NA years
The median has not been reached.
NA years
The median has not been reached.

SECONDARY outcome

Timeframe: from baseline up to 4 years

Population: All patients that were eligible and received treatment were analyzed.

To determine if longer therapy, 12 weeks, is superior to shorter therapy, 8 weeks, of either CA or paclitaxel for overall survival for women with primary breast cancer with 0-3 positive axillary lymph nodes. An assessment of the superiority of 6 cycles over 4 cycles will be conducted. This analysis combines Arm I and Arm III together, and Arm II and Arm IV together.

Outcome measures

Outcome measures
Measure
4 Cycles (Arm I and Arm III Combined)
n=1578 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
6 Cycles (Arm II and Arm IV Combined)
n=2293 Participants
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV OR paclitaxel over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS) for 4 vs. 6 Cycles
90.9 percentage of patients at 4 years
91.8 percentage of patients at 4 years

Adverse Events

Arm I (CA for 4 Courses)

Serious events: 113 serious events
Other events: 940 other events
Deaths: 0 deaths

Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])

Serious events: 104 serious events
Other events: 687 other events
Deaths: 0 deaths

Arm III (Paclitaxel for 4 Courses)

Serious events: 59 serious events
Other events: 975 other events
Deaths: 0 deaths

Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])

Serious events: 53 serious events
Other events: 668 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Arm I (CA for 4 Courses)
n=1110 participants at risk；n=1142 participants at risk
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])
n=765 participants at risk；n=789 participants at risk
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm III (Paclitaxel for 4 Courses)
n=1118 participants at risk；n=1151 participants at risk
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])
n=762 participants at risk；n=789 participants at risk
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Infections and infestations
Urinary tract infection
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Infections and infestations
Wound infection
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Blood and lymphatic system disorders
Blood disorder
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Blood and lymphatic system disorders
Febrile neutropenia
2.7%
30/1110 • Number of events 35
3.8%
29/765 • Number of events 33
0.09%
1/1118 • Number of events 1
0.00%
0/762
Blood and lymphatic system disorders
Hemoglobin decreased
7.3%
81/1110 • Number of events 112
8.4%
64/765 • Number of events 88
2.6%
29/1118 • Number of events 34
2.5%
19/762 • Number of events 21
Blood and lymphatic system disorders
Transfusion: pRBCs
0.27%
3/1110 • Number of events 4
0.65%
5/765 • Number of events 6
0.18%
2/1118 • Number of events 2
0.13%
1/762 • Number of events 1
Cardiac disorders
Arrhythmia
0.54%
6/1110 • Number of events 6
0.65%
5/765 • Number of events 6
0.63%
7/1118 • Number of events 8
0.26%
2/762 • Number of events 4
Cardiac disorders
Atrial fibrillation
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Cardiac disorders
Cardiac disorder
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Cardiac disorders
Cardiac pain
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Cardiac disorders
Edema
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Cardiac disorders
Left ventricular failure
0.09%
1/1110 • Number of events 1
0.65%
5/765 • Number of events 5
0.09%
1/1118 • Number of events 1
0.00%
0/762
Cardiac disorders
Myocardial ischemia
0.18%
2/1110 • Number of events 2
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Ear and labyrinth disorders
Vertigo
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Eye disorders
Photophobia
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Eye disorders
Vision blurred
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Abdominal pain
0.09%
1/1110 • Number of events 2
0.00%
0/765
0.36%
4/1118 • Number of events 5
0.13%
1/762 • Number of events 1
Gastrointestinal disorders
Colitis
0.18%
2/1110 • Number of events 2
0.26%
2/765 • Number of events 2
0.09%
1/1118 • Number of events 1
0.00%
0/762
Gastrointestinal disorders
Constipation
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Diarrhea
2.4%
27/1110 • Number of events 32
3.1%
24/765 • Number of events 27
0.98%
11/1118 • Number of events 11
0.66%
5/762 • Number of events 5
Gastrointestinal disorders
Dyspepsia
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Dysphagia
0.00%
0/1110
0.26%
2/765 • Number of events 2
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Esophagitis
0.36%
4/1110 • Number of events 4
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Gastric hemorrhage
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Gastrointestinal disorders
Gastric ulcer
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Gastrointestinal disorders
Gastrointestinal disorder
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.26%
2/762 • Number of events 2
Gastrointestinal disorders
Melena/GI bleeding
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Mucositis oral
3.5%
39/1110 • Number of events 61
3.9%
30/765 • Number of events 43
0.63%
7/1118 • Number of events 9
0.52%
4/762 • Number of events 4
Gastrointestinal disorders
Nausea
1.1%
12/1110 • Number of events 15
1.0%
8/765 • Number of events 9
0.63%
7/1118 • Number of events 8
0.39%
3/762 • Number of events 3
Gastrointestinal disorders
Pancreatitis
0.00%
0/1110
0.26%
2/765 • Number of events 2
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Rectal bleeding/hematochezia
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Rectal hemorrhage
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Rectal pain
0.18%
2/1110 • Number of events 2
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Typhlitis
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Vomiting
0.63%
7/1110 • Number of events 8
1.2%
9/765 • Number of events 10
0.45%
5/1118 • Number of events 6
0.13%
1/762 • Number of events 1
General disorders
Chest pain
0.27%
3/1110 • Number of events 3
0.26%
2/765 • Number of events 2
0.09%
1/1118 • Number of events 1
0.39%
3/762 • Number of events 3
General disorders
Chills
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
General disorders
Fatigue
1.3%
14/1110 • Number of events 16
1.6%
12/765 • Number of events 13
0.36%
4/1118 • Number of events 5
0.79%
6/762 • Number of events 6
General disorders
Fever
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.26%
2/762 • Number of events 2
General disorders
Gait abnormal
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
General disorders
Pain
0.27%
3/1110 • Number of events 4
0.26%
2/765 • Number of events 2
0.00%
0/1118
0.52%
4/762 • Number of events 4
Immune system disorders
Hypersensitivity
0.09%
1/1110 • Number of events 1
0.26%
2/765 • Number of events 2
0.36%
4/1118 • Number of events 4
0.79%
6/762 • Number of events 7
Infections and infestations
Catheter related infection
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.18%
2/1118 • Number of events 2
0.13%
1/762 • Number of events 1
Infections and infestations
Eye infection intraocular
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Infections and infestations
Infection
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Infections and infestations
Infection with grade 3 or 4 neutropenia
0.90%
10/1110 • Number of events 10
1.0%
8/765 • Number of events 8
0.00%
0/1118
0.00%
0/762
Infections and infestations
Infection with unknown ANC
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Infections and infestations
Infection without neutropenia
0.63%
7/1110 • Number of events 8
0.65%
5/765 • Number of events 5
0.63%
7/1118 • Number of events 7
0.39%
3/762 • Number of events 3
Infections and infestations
Infectious colitis
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Infections and infestations
Peripheral nerve infection
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Infections and infestations
Skin infection
0.18%
2/1110 • Number of events 2
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Infections and infestations
Soft tissue infection
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Infections and infestations
Tooth infection
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Infections and infestations
Wound-infectious
0.18%
2/1110 • Number of events 2
0.39%
3/765 • Number of events 3
0.00%
0/1118
0.00%
0/762
Injury, poisoning and procedural complications
Vascular access complication
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Injury, poisoning and procedural complications
Wound dehiscence
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Investigations
Activated partial thromboplastin time prolonged
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 2
0.13%
1/762 • Number of events 1
Investigations
Alanine aminotransferase increased
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.52%
4/762 • Number of events 4
Investigations
Alkaline phosphatase
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Investigations
Amylase increased
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Investigations
Aspartate aminotransferase increased
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.26%
2/762 • Number of events 2
Investigations
Blood bilirubin increased
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Investigations
Cardiac troponin T increased
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Investigations
Creatinine increased
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Investigations
Fibrinogen for leukemia studies
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Investigations
INR increased
0.09%
1/1110 • Number of events 2
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Investigations
Laboratory test abnormal
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Investigations
Leukocyte count decreased
6.0%
67/1110 • Number of events 90
8.6%
66/765 • Number of events 105
0.72%
8/1118 • Number of events 10
0.26%
2/762 • Number of events 2
Investigations
Lipase increased
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Investigations
Lymphocyte count decreased
0.36%
4/1110 • Number of events 4
0.52%
4/765 • Number of events 7
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Investigations
Neutrophil count decreased
5.9%
66/1110 • Number of events 87
8.0%
61/765 • Number of events 98
0.89%
10/1118 • Number of events 11
0.52%
4/762 • Number of events 4
Investigations
Platelet count decreased
3.6%
40/1110 • Number of events 51
4.7%
36/765 • Number of events 51
0.27%
3/1118 • Number of events 5
0.66%
5/762 • Number of events 6
Metabolism and nutrition disorders
Anorexia
0.45%
5/1110 • Number of events 5
0.39%
3/765 • Number of events 3
0.09%
1/1118 • Number of events 2
0.00%
0/762
Metabolism and nutrition disorders
Blood glucose increased
0.36%
4/1110 • Number of events 5
0.26%
2/765 • Number of events 2
0.36%
4/1118 • Number of events 6
0.66%
5/762 • Number of events 6
Metabolism and nutrition disorders
Dehydration
1.1%
12/1110 • Number of events 13
1.0%
8/765 • Number of events 8
0.27%
3/1118 • Number of events 3
0.26%
2/762 • Number of events 2
Metabolism and nutrition disorders
Serum albumin decreased
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Metabolism and nutrition disorders
Serum calcium decreased
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Metabolism and nutrition disorders
Serum glucose decreased
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Metabolism and nutrition disorders
Serum potassium decreased
0.72%
8/1110 • Number of events 9
0.26%
2/765 • Number of events 2
0.09%
1/1118 • Number of events 2
0.00%
0/762
Metabolism and nutrition disorders
Serum potassium increased
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Metabolism and nutrition disorders
Serum sodium decreased
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Musculoskeletal and connective tissue disorders
Arthralgia
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.66%
5/762 • Number of events 6
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Musculoskeletal and connective tissue disorders
Bone pain
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.27%
3/1118 • Number of events 3
0.00%
0/762
Musculoskeletal and connective tissue disorders
Muscle weakness
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.36%
4/1118 • Number of events 4
0.66%
5/762 • Number of events 6
Musculoskeletal and connective tissue disorders
Pain in extremity
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Nervous system disorders
Arachnoiditis
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Nervous system disorders
Ataxia
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Nervous system disorders
Depressed level of consciousness
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Nervous system disorders
Dizziness
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.13%
1/762 • Number of events 1
Nervous system disorders
Dysgeusia
0.18%
2/1110 • Number of events 2
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Nervous system disorders
Headache
0.36%
4/1110 • Number of events 4
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.52%
4/762 • Number of events 4
Nervous system disorders
Ischemia cerebrovascular
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Nervous system disorders
Memory impairment
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Nervous system disorders
Neuralgia
0.09%
1/1110 • Number of events 2
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Nervous system disorders
Peripheral motor neuropathy
0.27%
3/1110 • Number of events 4
0.00%
0/765
0.36%
4/1118 • Number of events 6
0.92%
7/762 • Number of events 8
Nervous system disorders
Peripheral sensory neuropathy
0.81%
9/1110 • Number of events 10
0.78%
6/765 • Number of events 7
2.1%
23/1118 • Number of events 27
3.3%
25/762 • Number of events 26
Nervous system disorders
Syncope
0.27%
3/1110 • Number of events 4
0.26%
2/765 • Number of events 2
0.00%
0/1118
0.52%
4/762 • Number of events 4
Nervous system disorders
Tremor
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Nervous system disorders
Vasovagal episode
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.26%
2/762 • Number of events 2
Psychiatric disorders
Anxiety
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Psychiatric disorders
Confusion
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.13%
1/762 • Number of events 1
Psychiatric disorders
Depression
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Psychiatric disorders
Hallucinations
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Psychiatric disorders
Insomnia
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Psychiatric disorders
Personality change
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Renal and urinary disorders
Dysuria (painful urination)
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Renal and urinary disorders
Renal failure
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Renal and urinary disorders
Urogenital disorder
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Reproductive system and breast disorders
Reproductive tract disorder
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Reproductive system and breast disorders
Vaginal hemorrhage
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Apnea
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Cough
0.18%
2/1110 • Number of events 2
0.26%
2/765 • Number of events 2
0.00%
0/1118
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.27%
3/1110 • Number of events 3
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
0.45%
5/1110 • Number of events 5
0.65%
5/765 • Number of events 5
0.09%
1/1118 • Number of events 1
0.39%
3/762 • Number of events 4
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Hemoptysis
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.09%
1/1110 • Number of events 1
0.26%
2/765 • Number of events 2
0.09%
1/1118 • Number of events 1
0.39%
3/762 • Number of events 3
Respiratory, thoracic and mediastinal disorders
Pharyngeal examination abnormal
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.18%
2/1110 • Number of events 2
0.92%
7/765 • Number of events 7
0.00%
0/1118
0.13%
1/762 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
0.09%
1/1110 • Number of events 1
0.26%
2/765 • Number of events 2
0.00%
0/1118
0.00%
0/762
Skin and subcutaneous tissue disorders
Alopecia
0.27%
3/1110 • Number of events 5
0.13%
1/765 • Number of events 1
0.27%
3/1118 • Number of events 3
0.13%
1/762 • Number of events 1
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
0.18%
2/1110 • Number of events 2
0.39%
3/765 • Number of events 3
0.00%
0/1118
0.00%
0/762
Skin and subcutaneous tissue disorders
Nail disorder
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Skin and subcutaneous tissue disorders
Skin disorder
0.18%
2/1110 • Number of events 2
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Skin and subcutaneous tissue disorders
Sweating
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Vascular disorders
Capillary leak syndrome
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Vascular disorders
Hematoma
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Vascular disorders
Hemorrhage
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Vascular disorders
Hemorrhage/bleeding without grade 3 or 4 thrombocytopenia
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Vascular disorders
Hypertension
0.00%
0/1110
0.00%
0/765
0.27%
3/1118 • Number of events 3
0.13%
1/762 • Number of events 1
Vascular disorders
Hypotension
0.27%
3/1110 • Number of events 3
0.39%
3/765 • Number of events 3
0.00%
0/1118
0.26%
2/762 • Number of events 2
Vascular disorders
Thrombosis
0.72%
8/1110 • Number of events 8
0.92%
7/765 • Number of events 7
0.54%
6/1118 • Number of events 6
0.52%
4/762 • Number of events 4

Other adverse events

Other adverse events
Measure
Arm I (CA for 4 Courses)
n=1110 participants at risk；n=1142 participants at risk
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm II (CA for 6 Courses [Closed to Accrual 12/15/2007])
n=765 participants at risk；n=789 participants at risk
Patients receive cyclophosphamide IV and doxorubicin hydrochloride IV on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Arm III (Paclitaxel for 4 Courses)
n=1118 participants at risk；n=1151 participants at risk
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Arm IV (Paclitaxel for 6 Courses [Closed 12/15/2007])
n=762 participants at risk；n=789 participants at risk
Patients receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
Blood and lymphatic system disorders
Anemia
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 2
0.00%
0/762
Blood and lymphatic system disorders
Febrile neutropenia
4.0%
44/1110 • Number of events 52
4.3%
33/765 • Number of events 41
0.27%
3/1118 • Number of events 3
0.13%
1/762 • Number of events 1
Blood and lymphatic system disorders
Hemoglobin decreased
62.9%
698/1110 • Number of events 1742
67.8%
519/765 • Number of events 1789
39.4%
440/1118 • Number of events 990
44.2%
337/762 • Number of events 1034
Blood and lymphatic system disorders
Hemolysis
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Blood and lymphatic system disorders
Lymphatic disorder
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.26%
2/762 • Number of events 2
Blood and lymphatic system disorders
Lymphatics
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Blood and lymphatic system disorders
Transfusion: Platelets
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Blood and lymphatic system disorders
Transfusion: pRBCs
0.18%
2/1110 • Number of events 2
1.0%
8/765 • Number of events 13
0.00%
0/1118
0.26%
2/762 • Number of events 3
Cardiac disorders
Arrhythmia
3.2%
35/1110 • Number of events 53
4.2%
32/765 • Number of events 49
3.5%
39/1118 • Number of events 57
3.0%
23/762 • Number of events 33
Cardiac disorders
Arrhythmia supraventricular
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Cardiac disorders
Atrial tachycardia
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Cardiac disorders
Cardiac disorder
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Cardiac disorders
Cardiac pain
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Cardiac disorders
Edema
0.00%
0/1110
0.65%
5/765 • Number of events 5
0.36%
4/1118 • Number of events 6
1.2%
9/762 • Number of events 16
Cardiac disorders
Left ventricular failure
1.8%
20/1110 • Number of events 32
1.7%
13/765 • Number of events 19
2.3%
26/1118 • Number of events 47
2.9%
22/762 • Number of events 55
Cardiac disorders
Myocardial ischemia
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Cardiac disorders
Palpitations
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Cardiac disorders
Restrictive cardiomyopathy
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Cardiac disorders
Sinus bradycardia
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Cardiac disorders
Sinus tachycardia
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.26%
2/762 • Number of events 2
Ear and labyrinth disorders
Ear disorder
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Ear and labyrinth disorders
Ear pain
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Ear and labyrinth disorders
Hearing impaired
0.00%
0/1110
0.00%
0/765
0.18%
2/1118 • Number of events 2
0.13%
1/762 • Number of events 1
Ear and labyrinth disorders
Middle ear inflammation
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Eye disorders
Conjunctivitis
0.00%
0/1110
0.39%
3/765 • Number of events 4
0.00%
0/1118
0.00%
0/762
Eye disorders
Diplopia
0.09%
1/1110 • Number of events 2
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Eye disorders
Dry eye syndrome
0.09%
1/1110 • Number of events 1
0.26%
2/765 • Number of events 3
0.00%
0/1118
0.13%
1/762 • Number of events 2
Eye disorders
Eye disorder
0.27%
3/1110 • Number of events 3
0.39%
3/765 • Number of events 5
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 2
Eye disorders
Flashing vision
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Eye disorders
Photophobia
0.00%
0/1110
0.39%
3/765 • Number of events 6
0.00%
0/1118
0.13%
1/762 • Number of events 1
Eye disorders
Vision blurred
0.27%
3/1110 • Number of events 4
0.52%
4/765 • Number of events 7
0.36%
4/1118 • Number of events 4
0.00%
0/762
Eye disorders
Watering eyes
0.36%
4/1110 • Number of events 5
0.39%
3/765 • Number of events 4
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Gastrointestinal disorders
Abdominal distension
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Gastrointestinal disorders
Abdominal pain
0.63%
7/1110 • Number of events 9
0.26%
2/765 • Number of events 2
0.89%
10/1118 • Number of events 11
0.79%
6/762 • Number of events 6
Gastrointestinal disorders
Anal pain
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Constipation
2.1%
23/1110 • Number of events 35
2.5%
19/765 • Number of events 26
1.2%
13/1118 • Number of events 14
2.0%
15/762 • Number of events 21
Gastrointestinal disorders
Diarrhea
21.2%
235/1110 • Number of events 374
25.6%
196/765 • Number of events 328
21.6%
241/1118 • Number of events 349
23.2%
177/762 • Number of events 340
Gastrointestinal disorders
Dry mouth
0.18%
2/1110 • Number of events 3
0.26%
2/765 • Number of events 5
0.27%
3/1118 • Number of events 3
0.13%
1/762 • Number of events 1
Gastrointestinal disorders
Duodenal ulcer
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Gastrointestinal disorders
Dyspepsia
0.90%
10/1110 • Number of events 15
0.92%
7/765 • Number of events 9
0.27%
3/1118 • Number of events 4
0.52%
4/762 • Number of events 4
Gastrointestinal disorders
Dysphagia
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Esophageal pain
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Esophagitis
0.81%
9/1110 • Number of events 9
0.65%
5/765 • Number of events 7
0.00%
0/1118
0.26%
2/762 • Number of events 4
Gastrointestinal disorders
Flatulence
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.26%
2/762 • Number of events 3
Gastrointestinal disorders
Gastritis
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.13%
1/762 • Number of events 1
Gastrointestinal disorders
Gastrointestinal disorder
0.27%
3/1110 • Number of events 3
0.00%
0/765
0.36%
4/1118 • Number of events 4
0.00%
0/762
Gastrointestinal disorders
Hemorrhoids
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Melena/GI bleeding
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.13%
1/762 • Number of events 1
Gastrointestinal disorders
Mucositis oral
33.2%
368/1110 • Number of events 639
41.6%
318/765 • Number of events 705
11.8%
132/1118 • Number of events 179
15.1%
115/762 • Number of events 189
Gastrointestinal disorders
Nausea
7.1%
79/1110 • Number of events 140
8.8%
67/765 • Number of events 126
2.2%
25/1118 • Number of events 35
2.6%
20/762 • Number of events 34
Gastrointestinal disorders
Pancreatitis
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Gastrointestinal disorders
Rectal bleeding/hematochezia
0.18%
2/1110 • Number of events 3
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Rectal pain
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis) for BMT studies, if specified in
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 2
0.00%
0/762
Gastrointestinal disorders
Vomiting
4.9%
54/1110 • Number of events 70
4.2%
32/765 • Number of events 41
0.54%
6/1118 • Number of events 6
0.52%
4/762 • Number of events 4
General disorders
Chest pain
0.27%
3/1110 • Number of events 3
0.52%
4/765 • Number of events 4
0.27%
3/1118 • Number of events 3
0.26%
2/762 • Number of events 3
General disorders
Chills
0.09%
1/1110 • Number of events 2
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
General disorders
Dysmenorrhea
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
General disorders
Edema limbs
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
General disorders
Fatigue
6.6%
73/1110 • Number of events 137
10.2%
78/765 • Number of events 155
4.9%
55/1118 • Number of events 93
6.8%
52/762 • Number of events 100
General disorders
Fever
0.18%
2/1110 • Number of events 3
0.26%
2/765 • Number of events 2
0.27%
3/1118 • Number of events 4
0.26%
2/762 • Number of events 2
General disorders
General symptom
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
General disorders
Ill-defined disorder
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
General disorders
Injection site reaction
0.18%
2/1110 • Number of events 2
0.26%
2/765 • Number of events 3
0.27%
3/1118 • Number of events 5
0.00%
0/762
General disorders
Pain
0.81%
9/1110 • Number of events 12
1.0%
8/765 • Number of events 12
0.89%
10/1118 • Number of events 11
1.4%
11/762 • Number of events 12
Hepatobiliary disorders
Hepatic hemorrhage
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Hepatobiliary disorders
Hepatic pain
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Hepatobiliary disorders
Hepatobiliary disease
0.18%
2/1110 • Number of events 2
0.00%
0/765
0.09%
1/1118 • Number of events 2
0.00%
0/762
Immune system disorders
Hypersensitivity
1.1%
12/1110 • Number of events 20
1.3%
10/765 • Number of events 13
9.6%
107/1118 • Number of events 149
8.3%
63/762 • Number of events 98
Immune system disorders
Immune system disorder
0.00%
0/1110
0.26%
2/765 • Number of events 2
0.09%
1/1118 • Number of events 1
0.00%
0/762
Infections and infestations
Bladder infection
0.00%
0/1110
0.26%
2/765 • Number of events 4
0.00%
0/1118
0.00%
0/762
Infections and infestations
Bronchitis
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Infections and infestations
Catheter related infection
0.18%
2/1110 • Number of events 2
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.39%
3/762 • Number of events 3
Infections and infestations
Conjunctivitis infective
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Infections and infestations
Device related infection
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Infections and infestations
Infection
0.45%
5/1110 • Number of events 5
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Infections and infestations
Infection with grade 3 or 4 neutropenia
0.63%
7/1110 • Number of events 7
1.6%
12/765 • Number of events 12
0.00%
0/1118
0.13%
1/762 • Number of events 2
Infections and infestations
Infection with unknown ANC
0.18%
2/1110 • Number of events 2
0.39%
3/765 • Number of events 3
0.00%
0/1118
0.00%
0/762
Infections and infestations
Infection without neutropenia
1.5%
17/1110 • Number of events 19
2.0%
15/765 • Number of events 15
1.3%
14/1118 • Number of events 15
1.0%
8/762 • Number of events 8
Infections and infestations
Otitis externa
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Infections and infestations
Sinusitis
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Infections and infestations
Skin infection
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.13%
1/762 • Number of events 2
Infections and infestations
Tooth infection
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Infections and infestations
Upper respiratory infection
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Infections and infestations
Urinary tract infection
0.18%
2/1110 • Number of events 2
0.39%
3/765 • Number of events 3
0.00%
0/1118
0.00%
0/762
Infections and infestations
Vaginal infection
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Infections and infestations
Wound infection
0.18%
2/1110 • Number of events 4
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 2
0.13%
1/762 • Number of events 1
Infections and infestations
Wound-infectious
0.09%
1/1110 • Number of events 1
0.26%
2/765 • Number of events 4
0.18%
2/1118 • Number of events 2
0.00%
0/762
Injury, poisoning and procedural complications
Bruising
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Injury, poisoning and procedural complications
Dermatitis radiation
0.09%
1/1110 • Number of events 3
0.00%
0/765
0.18%
2/1118 • Number of events 2
0.00%
0/762
Injury, poisoning and procedural complications
Postoperative thoracic procedure complication
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Injury, poisoning and procedural complications
Seroma
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 2
0.00%
0/762
Injury, poisoning and procedural complications
Vascular access complication
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.39%
3/762 • Number of events 4
Injury, poisoning and procedural complications
Wound dehiscence
0.09%
1/1110 • Number of events 2
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Investigations
Activated partial thromboplastin time prolonged
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Investigations
Alanine aminotransferase increased
0.90%
10/1110 • Number of events 10
0.92%
7/765 • Number of events 7
2.2%
25/1118 • Number of events 28
1.8%
14/762 • Number of events 21
Investigations
Alkaline phosphatase
0.36%
4/1110 • Number of events 4
0.65%
5/765 • Number of events 8
0.89%
10/1118 • Number of events 16
1.4%
11/762 • Number of events 22
Investigations
Alkaline phosphatase increased
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.45%
5/1118 • Number of events 8
0.13%
1/762 • Number of events 1
Investigations
Aspartate aminotransferase increased
0.54%
6/1110 • Number of events 6
0.92%
7/765 • Number of events 7
1.2%
13/1118 • Number of events 17
0.92%
7/762 • Number of events 14
Investigations
Blood bilirubin increased
0.00%
0/1110
0.00%
0/765
0.36%
4/1118 • Number of events 4
0.52%
4/762 • Number of events 6
Investigations
Coagulopathy
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Investigations
Creatine phosphokinase increased
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Investigations
Creatinine increased
0.18%
2/1110 • Number of events 4
0.52%
4/765 • Number of events 8
0.36%
4/1118 • Number of events 4
0.39%
3/762 • Number of events 3
Investigations
Electrocardiogram QTc interval prolonged
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Investigations
Gamma-glutamyltransferase increased
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 4
0.18%
2/1118 • Number of events 5
0.00%
0/762
Investigations
INR increased
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.13%
1/762 • Number of events 1
Investigations
Laboratory test abnormal
0.09%
1/1110 • Number of events 1
0.26%
2/765 • Number of events 4
0.18%
2/1118 • Number of events 4
0.00%
0/762
Investigations
Leukocyte count decreased
38.4%
426/1110 • Number of events 845
46.8%
358/765 • Number of events 929
17.8%
199/1118 • Number of events 319
18.8%
143/762 • Number of events 289
Investigations
Lipase increased
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Investigations
Lymphocyte count decreased
1.9%
21/1110 • Number of events 26
1.2%
9/765 • Number of events 13
0.72%
8/1118 • Number of events 12
0.39%
3/762 • Number of events 3
Investigations
Neutrophil count decreased
31.8%
353/1110 • Number of events 683
40.4%
309/765 • Number of events 774
13.0%
145/1118 • Number of events 207
15.1%
115/762 • Number of events 198
Investigations
Platelet count decreased
18.5%
205/1110 • Number of events 360
22.1%
169/765 • Number of events 379
11.2%
125/1118 • Number of events 209
11.9%
91/762 • Number of events 161
Investigations
Weight gain
0.18%
2/1110 • Number of events 2
0.52%
4/765 • Number of events 5
0.09%
1/1118 • Number of events 1
0.26%
2/762 • Number of events 2
Investigations
Weight loss
0.36%
4/1110 • Number of events 5
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Investigations
Leukopenia
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Metabolism and nutrition disorders
Anorexia
0.99%
11/1110 • Number of events 13
1.0%
8/765 • Number of events 12
0.45%
5/1118 • Number of events 9
0.52%
4/762 • Number of events 8
Metabolism and nutrition disorders
Blood bicarbonate decreased
0.09%
1/1110 • Number of events 2
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 5
Metabolism and nutrition disorders
Blood glucose increased
3.0%
33/1110 • Number of events 61
3.4%
26/765 • Number of events 55
5.1%
57/1118 • Number of events 101
5.2%
40/762 • Number of events 85
Metabolism and nutrition disorders
Blood uric acid increased
0.00%
0/1110
0.00%
0/765
0.18%
2/1118 • Number of events 4
0.00%
0/762
Metabolism and nutrition disorders
Dehydration
1.1%
12/1110 • Number of events 16
0.26%
2/765 • Number of events 3
0.09%
1/1118 • Number of events 1
0.00%
0/762
Metabolism and nutrition disorders
Serum albumin decreased
0.27%
3/1110 • Number of events 3
0.13%
1/765 • Number of events 1
0.45%
5/1118 • Number of events 8
0.26%
2/762 • Number of events 2
Metabolism and nutrition disorders
Serum calcium decreased
0.27%
3/1110 • Number of events 4
0.39%
3/765 • Number of events 4
0.27%
3/1118 • Number of events 3
0.26%
2/762 • Number of events 2
Metabolism and nutrition disorders
Serum glucose decreased
0.18%
2/1110 • Number of events 2
0.52%
4/765 • Number of events 5
0.09%
1/1118 • Number of events 1
0.26%
2/762 • Number of events 5
Metabolism and nutrition disorders
Serum magnesium decreased
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Metabolism and nutrition disorders
Serum potassium decreased
1.2%
13/1110 • Number of events 21
1.2%
9/765 • Number of events 15
0.72%
8/1118 • Number of events 8
0.92%
7/762 • Number of events 10
Metabolism and nutrition disorders
Serum potassium increased
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.27%
3/1118 • Number of events 3
0.66%
5/762 • Number of events 5
Metabolism and nutrition disorders
Serum sodium decreased
0.45%
5/1110 • Number of events 8
0.39%
3/765 • Number of events 3
0.45%
5/1118 • Number of events 6
0.92%
7/762 • Number of events 15
Metabolism and nutrition disorders
Serum sodium increased
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Metabolism and nutrition disorders
Serum triglycerides increased
0.09%
1/1110 • Number of events 3
0.39%
3/765 • Number of events 5
0.00%
0/1118
0.00%
0/762
Musculoskeletal and connective tissue disorders
Arthralgia
0.63%
7/1110 • Number of events 7
1.0%
8/765 • Number of events 11
4.1%
46/1118 • Number of events 68
4.9%
37/762 • Number of events 64
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/1110
0.00%
0/765
0.27%
3/1118 • Number of events 3
0.00%
0/762
Musculoskeletal and connective tissue disorders
Bone pain
0.72%
8/1110 • Number of events 10
1.0%
8/765 • Number of events 10
4.7%
52/1118 • Number of events 68
3.3%
25/762 • Number of events 37
Musculoskeletal and connective tissue disorders
Muscle weakness
0.18%
2/1110 • Number of events 3
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
0.18%
2/1110 • Number of events 2
0.26%
2/765 • Number of events 2
0.00%
0/1118
0.26%
2/762 • Number of events 2
Musculoskeletal and connective tissue disorders
Myalgia
0.54%
6/1110 • Number of events 7
1.2%
9/765 • Number of events 12
4.7%
52/1118 • Number of events 73
6.4%
49/762 • Number of events 82
Musculoskeletal and connective tissue disorders
Myositis
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Musculoskeletal and connective tissue disorders
Pain in extremity
0.09%
1/1110 • Number of events 2
0.00%
0/765
0.54%
6/1118 • Number of events 12
0.26%
2/762 • Number of events 2
Nervous system disorders
Ataxia
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Nervous system disorders
Dizziness
0.36%
4/1110 • Number of events 5
0.26%
2/765 • Number of events 2
0.81%
9/1118 • Number of events 10
0.26%
2/762 • Number of events 2
Nervous system disorders
Dysgeusia
0.36%
4/1110 • Number of events 5
0.52%
4/765 • Number of events 12
0.63%
7/1118 • Number of events 8
0.79%
6/762 • Number of events 13
Nervous system disorders
Extrapyramidal disorder
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 2
Nervous system disorders
Headache
1.7%
19/1110 • Number of events 25
2.5%
19/765 • Number of events 26
1.3%
14/1118 • Number of events 19
1.6%
12/762 • Number of events 18
Nervous system disorders
Ischemia cerebrovascular
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Nervous system disorders
Neuralgia
0.00%
0/1110
0.00%
0/765
0.27%
3/1118 • Number of events 3
0.92%
7/762 • Number of events 11
Nervous system disorders
Neurological disorder NOS
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Nervous system disorders
Nystagmus
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Nervous system disorders
Peripheral motor neuropathy
1.5%
17/1110 • Number of events 20
2.5%
19/765 • Number of events 22
9.8%
110/1118 • Number of events 166
14.2%
108/762 • Number of events 221
Nervous system disorders
Peripheral sensory neuropathy
8.6%
95/1110 • Number of events 153
13.2%
101/765 • Number of events 182
58.1%
650/1118 • Number of events 1621
67.3%
513/762 • Number of events 1786
Nervous system disorders
Seizure
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Nervous system disorders
Sense of smell
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Nervous system disorders
Syncope
0.36%
4/1110 • Number of events 4
0.26%
2/765 • Number of events 2
0.45%
5/1118 • Number of events 5
0.66%
5/762 • Number of events 5
Nervous system disorders
Tremor
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Nervous system disorders
Vasovagal episode
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Nervous system disorders
Neuro-Sensory
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Investigations
Neutropenia
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Psychiatric disorders
Anxiety
0.54%
6/1110 • Number of events 7
0.65%
5/765 • Number of events 6
0.54%
6/1118 • Number of events 11
1.3%
10/762 • Number of events 11
Psychiatric disorders
Confusion
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Psychiatric disorders
Depression
0.54%
6/1110 • Number of events 7
0.52%
4/765 • Number of events 4
0.63%
7/1118 • Number of events 10
1.0%
8/762 • Number of events 15
Psychiatric disorders
Hallucinations
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Psychiatric disorders
Insomnia
0.90%
10/1110 • Number of events 13
0.92%
7/765 • Number of events 12
0.72%
8/1118 • Number of events 10
0.92%
7/762 • Number of events 10
Psychiatric disorders
Libido decreased
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Renal and urinary disorders
Bladder pain
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Renal and urinary disorders
Dysuria (painful urination)
0.09%
1/1110 • Number of events 2
0.39%
3/765 • Number of events 3
0.09%
1/1118 • Number of events 1
0.39%
3/762 • Number of events 3
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Renal and urinary disorders
Incontinence
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.27%
3/1118 • Number of events 3
0.13%
1/762 • Number of events 1
Renal and urinary disorders
Ureteric obstruction
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Renal and urinary disorders
Urethral hemorrhage
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Renal and urinary disorders
Urinary frequency
0.00%
0/1110
0.52%
4/765 • Number of events 4
0.18%
2/1118 • Number of events 2
0.26%
2/762 • Number of events 2
Renal and urinary disorders
Urine discoloration
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.13%
1/762 • Number of events 1
Renal and urinary disorders
Urogenital disorder
0.18%
2/1110 • Number of events 2
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Reproductive system and breast disorders
Irregular menstruation
0.54%
6/1110 • Number of events 8
0.65%
5/765 • Number of events 11
0.27%
3/1118 • Number of events 3
0.66%
5/762 • Number of events 6
Reproductive system and breast disorders
Pelvic pain
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Reproductive system and breast disorders
Reproductive tract disorder
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Reproductive system and breast disorders
Vaginal dryness
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Reproductive system and breast disorders
Vaginal hemorrhage
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.26%
2/762 • Number of events 2
Reproductive system and breast disorders
Vaginal inflammation
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 2
0.00%
0/1118
0.13%
1/762 • Number of events 1
Reproductive system and breast disorders
Vaginal mucositis
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
0.09%
1/1110 • Number of events 2
0.65%
5/765 • Number of events 10
0.18%
2/1118 • Number of events 2
0.39%
3/762 • Number of events 3
Respiratory, thoracic and mediastinal disorders
Apnea
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.13%
1/762 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Cough
0.45%
5/1110 • Number of events 6
1.3%
10/765 • Number of events 15
0.09%
1/1118 • Number of events 1
0.52%
4/762 • Number of events 5
Respiratory, thoracic and mediastinal disorders
Dyspnea
0.36%
4/1110 • Number of events 5
0.13%
1/765 • Number of events 2
0.18%
2/1118 • Number of events 2
0.26%
2/762 • Number of events 2
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
0.63%
7/1110 • Number of events 8
1.6%
12/765 • Number of events 17
0.81%
9/1118 • Number of events 10
1.0%
8/762 • Number of events 12
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.45%
5/1118 • Number of events 5
0.52%
4/762 • Number of events 5
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.13%
1/762 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 2
0.00%
0/1118
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/1110
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 1
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
0.27%
3/1110 • Number of events 3
0.39%
3/765 • Number of events 5
0.00%
0/1118
0.00%
0/762
Respiratory, thoracic and mediastinal disorders
Voice alteration
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 2
0.13%
1/762 • Number of events 1
Skin and subcutaneous tissue disorders
Alopecia
3.9%
43/1110 • Number of events 89
5.8%
44/765 • Number of events 90
3.3%
37/1118 • Number of events 64
5.2%
40/762 • Number of events 81
Skin and subcutaneous tissue disorders
Dry skin
0.09%
1/1110 • Number of events 1
0.52%
4/765 • Number of events 4
0.00%
0/1118
0.13%
1/762 • Number of events 2
Skin and subcutaneous tissue disorders
Erythema multiforme
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.13%
1/762 • Number of events 5
Skin and subcutaneous tissue disorders
Hand-and-foot syndrome
0.27%
3/1110 • Number of events 3
1.0%
8/765 • Number of events 11
0.00%
0/1118
0.26%
2/762 • Number of events 2
Skin and subcutaneous tissue disorders
Nail disorder
0.09%
1/1110 • Number of events 3
0.52%
4/765 • Number of events 6
0.36%
4/1118 • Number of events 4
0.39%
3/762 • Number of events 6
Skin and subcutaneous tissue disorders
Photosensitivity
0.00%
0/1110
0.13%
1/765 • Number of events 2
0.00%
0/1118
0.13%
1/762 • Number of events 2
Skin and subcutaneous tissue disorders
Pigmentation changes (e.g., vitiligo)
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.00%
0/762
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/1110
0.26%
2/765 • Number of events 6
0.63%
7/1118 • Number of events 11
0.79%
6/762 • Number of events 11
Skin and subcutaneous tissue disorders
Rash acneiform
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Skin and subcutaneous tissue disorders
Rash desquamating
0.45%
5/1110 • Number of events 6
0.52%
4/765 • Number of events 4
1.3%
14/1118 • Number of events 20
2.2%
17/762 • Number of events 24
Skin and subcutaneous tissue disorders
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
0.00%
0/1110
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Skin and subcutaneous tissue disorders
Scalp pain
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.00%
0/1118
0.00%
0/762
Skin and subcutaneous tissue disorders
Skin disorder
0.18%
2/1110 • Number of events 2
0.13%
1/765 • Number of events 1
0.27%
3/1118 • Number of events 4
0.52%
4/762 • Number of events 8
Skin and subcutaneous tissue disorders
Sweating
0.18%
2/1110 • Number of events 3
0.52%
4/765 • Number of events 7
0.18%
2/1118 • Number of events 3
0.26%
2/762 • Number of events 3
Gastrointestinal disorders
Stomatitis
0.00%
0/1110
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Vascular disorders
Flushing
0.00%
0/1110
0.00%
0/765
0.18%
2/1118 • Number of events 6
0.39%
3/762 • Number of events 8
Vascular disorders
Hemorrhage
0.09%
1/1110 • Number of events 1
0.00%
0/765
0.09%
1/1118 • Number of events 1
0.00%
0/762
Vascular disorders
Hot flashes
1.4%
15/1110 • Number of events 20
1.4%
11/765 • Number of events 21
1.5%
17/1118 • Number of events 27
1.2%
9/762 • Number of events 12
Vascular disorders
Hypertension
0.09%
1/1110 • Number of events 2
0.00%
0/765
0.89%
10/1118 • Number of events 15
1.0%
8/762 • Number of events 12
Vascular disorders
Hypotension
0.18%
2/1110 • Number of events 2
0.13%
1/765 • Number of events 1
0.09%
1/1118 • Number of events 1
0.26%
2/762 • Number of events 2
Vascular disorders
Phlebitis
0.09%
1/1110 • Number of events 1
0.13%
1/765 • Number of events 1
0.00%
0/1118
0.00%
0/762
Vascular disorders
Thrombosis
0.90%
10/1110 • Number of events 11
1.6%
12/765 • Number of events 26
0.27%
3/1118 • Number of events 4
0.66%
5/762 • Number of events 8

Additional Information

Lawrence N. Shulman, M.D.

Dana-Farber Cancer Institute

Phone: (617)-632-2277

Results disclosure agreements

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

Restriction type: LTE60