Trial Outcomes & Findings for Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes (NCT NCT00003782)
NCT ID: NCT00003782
Last Updated: 2024-03-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
5351 participants
Primary outcome timeframe
8 years
Results posted on
2024-03-21
Participant Flow
Participant milestones
| Measure |
Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel
Doxorubicin + Cyclophosphamide, then Docetaxel
|
Arm 2: Doxorubicin + Docetaxel
Doxorubicin + Docetaxel
|
Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide
Doxorubicin + Docetaxel + Cyclophosphamide
|
|---|---|---|---|
|
Overall Study
STARTED
|
1783
|
1784
|
1784
|
|
Overall Study
COMPLETED
|
1753
|
1753
|
1758
|
|
Overall Study
NOT COMPLETED
|
30
|
31
|
26
|
Reasons for withdrawal
| Measure |
Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel
Doxorubicin + Cyclophosphamide, then Docetaxel
|
Arm 2: Doxorubicin + Docetaxel
Doxorubicin + Docetaxel
|
Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide
Doxorubicin + Docetaxel + Cyclophosphamide
|
|---|---|---|---|
|
Overall Study
No follow up data
|
30
|
31
|
26
|
Baseline Characteristics
Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes
Baseline characteristics by cohort
| Measure |
Doxorubicin + Cyclophosphamide, Then Docetaxel
n=1783 Participants
Doxorubicin + Cyclophosphamide, then Docetaxel
|
Doxorubicin + Docetaxel
n=1784 Participants
Doxorubicin + Docetaxel
|
Doxorubicin + Docetaxel + Cyclophosphamide
n=1784 Participants
Doxorubicin + Docetaxel + Cyclophosphamide
|
Total
n=5351 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
50 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
50 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
51 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
51 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1783 Participants
n=5 Participants
|
1784 Participants
n=7 Participants
|
1784 Participants
n=5 Participants
|
5351 Participants
n=4 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
|
PRIMARY outcome
Timeframe: 8 yearsOutcome measures
| Measure |
Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel
n=1753 Participants
Doxorubicin + Cyclophosphamide, then Docetaxel
|
Arm 2: Doxorubicin + Docetaxel
n=1753 Participants
Doxorubicin + Docetaxel
|
Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide
n=1758 Participants
Doxorubicin + Docetaxel + Cyclophosphamide
|
|---|---|---|---|
|
Overall Survival
|
83 percentage of patients alive
|
79 percentage of patients alive
|
79 percentage of patients alive
|
PRIMARY outcome
Timeframe: time to event: breast cancer recurrence; second primary cancer; death from any cause as a first eventOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 9 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 9 weeks, and 6, 12, 18, and 24 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline, 9 weeks, and 6, 12, 18, and 24 monthsOutcome measures
Outcome data not reported
Adverse Events
Doxorubicin + Cyclophosphamide, Then Docetaxel
Serious events: 66 serious events
Other events: 845 other events
Deaths: 0 deaths
Doxorubicin + Docetaxel
Serious events: 43 serious events
Other events: 561 other events
Deaths: 0 deaths
Doxorubicin + Docetaxel + Cyclophosphamide
Serious events: 46 serious events
Other events: 641 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxorubicin + Cyclophosphamide, Then Docetaxel
n=1748 participants at risk
Doxorubicin + Cyclophosphamide, then Docetaxel
|
Doxorubicin + Docetaxel
n=1748 participants at risk
Doxorubicin + Docetaxel
|
Doxorubicin + Docetaxel + Cyclophosphamide
n=1745 participants at risk
Doxorubicin + Docetaxel + Cyclophosphamide
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.11%
2/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Alanine aminotransferase increased (ALT/SGPT)
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Immune system disorders
Anaphylaxis
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.17%
3/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.11%
2/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Anxiety
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Aspartate aminotransferase increased (AST/SGOT)
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.11%
2/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
0.17%
3/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Colitis
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.11%
2/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Confusion
|
0.11%
2/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Creatinine increased
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.11%
2/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.11%
2/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Depression
|
0.29%
5/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.34%
6/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.11%
2/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.34%
6/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.17%
3/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.11%
2/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.40%
7/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Hepatobiliary disorders
Hepatobiliary disorders - Other, specify
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.80%
14/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.29%
5/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.11%
2/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Hypertension
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypertriglyceridemia
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Hypotension
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.51%
9/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.40%
7/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.57%
10/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
0.11%
2/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.23%
4/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.11%
2/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Neutrophil count decreased
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.11%
2/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Psychosis
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Thromboembolic event
|
0.69%
12/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.23%
4/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.46%
8/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Typhlitis
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.17%
3/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Vasovagal reaction
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Vomiting
|
0.11%
2/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Wound infection
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
White blood cell decreased
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Visceral arterial ischemia
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.11%
2/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.11%
2/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.00%
0/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1748
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1745
Participants at Risk includes any patient who submitted an AE form.
|
Other adverse events
| Measure |
Doxorubicin + Cyclophosphamide, Then Docetaxel
n=1748 participants at risk
Doxorubicin + Cyclophosphamide, then Docetaxel
|
Doxorubicin + Docetaxel
n=1748 participants at risk
Doxorubicin + Docetaxel
|
Doxorubicin + Docetaxel + Cyclophosphamide
n=1745 participants at risk
Doxorubicin + Docetaxel + Cyclophosphamide
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.2%
126/1748
Participants at Risk includes any patient who submitted an AE form.
|
1.3%
22/1748
Participants at Risk includes any patient who submitted an AE form.
|
1.9%
33/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
78/1748
Participants at Risk includes any patient who submitted an AE form.
|
3.8%
66/1748
Participants at Risk includes any patient who submitted an AE form.
|
6.4%
111/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Fatigue
|
12.1%
212/1748
Participants at Risk includes any patient who submitted an AE form.
|
7.7%
135/1748
Participants at Risk includes any patient who submitted an AE form.
|
9.6%
167/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
21.9%
383/1748
Participants at Risk includes any patient who submitted an AE form.
|
12.8%
223/1748
Participants at Risk includes any patient who submitted an AE form.
|
15.8%
275/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
11.4%
200/1748
Participants at Risk includes any patient who submitted an AE form.
|
8.2%
144/1748
Participants at Risk includes any patient who submitted an AE form.
|
7.9%
137/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.5%
148/1748
Participants at Risk includes any patient who submitted an AE form.
|
1.7%
29/1748
Participants at Risk includes any patient who submitted an AE form.
|
2.0%
35/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Nausea
|
9.3%
162/1748
Participants at Risk includes any patient who submitted an AE form.
|
7.3%
127/1748
Participants at Risk includes any patient who submitted an AE form.
|
8.9%
155/1745
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
140/1748
Participants at Risk includes any patient who submitted an AE form.
|
5.1%
90/1748
Participants at Risk includes any patient who submitted an AE form.
|
6.8%
119/1745
Participants at Risk includes any patient who submitted an AE form.
|
Additional Information
Director, Division of Regulatory Affairs
NSABP Foundation, Inc.
Phone: 412-330-4600
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60