Trial Outcomes & Findings for Docetaxel in Breast Cancer (NCT NCT00312208)
NCT ID: NCT00312208
Last Updated: 2013-12-30
Results Overview
The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
3299 participants
Primary outcome timeframe
Median follow-up 65 months
Results posted on
2013-12-30
Participant Flow
Participant milestones
| Measure |
Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)
AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
|
Docetaxel + Doxorubicin and Cyclophosphamide (TAC)
TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
|
|---|---|---|
|
Overall Study
STARTED
|
1649
|
1649
|
|
Overall Study
COMPLETED
|
1477
|
1526
|
|
Overall Study
NOT COMPLETED
|
172
|
123
|
Reasons for withdrawal
| Measure |
Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)
AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
|
Docetaxel + Doxorubicin and Cyclophosphamide (TAC)
TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
|
|---|---|---|
|
Overall Study
Adverse Event
|
97
|
61
|
|
Overall Study
Protocol Violation
|
5
|
3
|
|
Overall Study
Death
|
2
|
1
|
|
Overall Study
Lack of Efficacy
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
3
|
5
|
|
Overall Study
Withdrawal by Subject
|
53
|
42
|
|
Overall Study
Other
|
5
|
7
|
Baseline Characteristics
Docetaxel in Breast Cancer
Baseline characteristics by cohort
| Measure |
Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)
n=1649 Participants
AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
|
Docetaxel + Doxorubicin and Cyclophosphamide (TAC)
n=1649 Participants
TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
|
Total
n=3298 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
> =65 years
|
85 Participants
n=5 Participants
|
83 Participants
n=7 Participants
|
168 Participants
n=5 Participants
|
|
Age, Customized
Between 65 and 50 years
|
784 Participants
n=5 Participants
|
783 Participants
n=7 Participants
|
1567 Participants
n=5 Participants
|
|
Age, Customized
Between 49 and 35 years
|
689 Participants
n=5 Participants
|
710 Participants
n=7 Participants
|
1399 Participants
n=5 Participants
|
|
Age, Customized
< =35 years
|
91 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Age, Continuous
|
50 years
n=5 Participants
|
50 years
n=7 Participants
|
50 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
1649 Participants
n=5 Participants
|
1649 Participants
n=7 Participants
|
3298 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Argentina
|
31 participants
n=5 Participants
|
32 participants
n=7 Participants
|
63 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
156 participants
n=5 Participants
|
144 participants
n=7 Participants
|
300 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
33 participants
n=5 Participants
|
31 participants
n=7 Participants
|
64 participants
n=5 Participants
|
|
Region of Enrollment
Bosnia And Herzegovina
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Region of Enrollment
Brazil
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
11 participants
n=5 Participants
|
11 participants
n=7 Participants
|
22 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
174 participants
n=5 Participants
|
180 participants
n=7 Participants
|
354 participants
n=5 Participants
|
|
Region of Enrollment
China
|
21 participants
n=5 Participants
|
17 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
Colombia
|
6 participants
n=5 Participants
|
8 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Region of Enrollment
Croatia
|
29 participants
n=5 Participants
|
29 participants
n=7 Participants
|
58 participants
n=5 Participants
|
|
Region of Enrollment
Cyprus
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
11 participants
n=5 Participants
|
10 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Egypt
|
4 participants
n=5 Participants
|
4 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
France
|
59 participants
n=5 Participants
|
58 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
224 participants
n=5 Participants
|
223 participants
n=7 Participants
|
447 participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
Hong Kong
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
34 participants
n=5 Participants
|
35 participants
n=7 Participants
|
69 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
83 participants
n=5 Participants
|
88 participants
n=7 Participants
|
171 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
63 participants
n=5 Participants
|
67 participants
n=7 Participants
|
130 participants
n=5 Participants
|
|
Region of Enrollment
Lebanon
|
23 participants
n=5 Participants
|
18 participants
n=7 Participants
|
41 participants
n=5 Participants
|
|
Region of Enrollment
Mexico
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
21 participants
n=5 Participants
|
19 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
167 participants
n=5 Participants
|
168 participants
n=7 Participants
|
335 participants
n=5 Participants
|
|
Region of Enrollment
Portugal
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Russian Federation
|
32 participants
n=5 Participants
|
35 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
17 participants
n=5 Participants
|
19 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Region of Enrollment
Saudi Arabia
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Slovenia
|
15 participants
n=5 Participants
|
17 participants
n=7 Participants
|
32 participants
n=5 Participants
|
|
Region of Enrollment
South Africa
|
19 participants
n=5 Participants
|
21 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Region of Enrollment
South Korea
|
22 participants
n=5 Participants
|
27 participants
n=7 Participants
|
49 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
26 participants
n=5 Participants
|
41 participants
n=7 Participants
|
67 participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
18 participants
n=5 Participants
|
16 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
294 participants
n=5 Participants
|
278 participants
n=7 Participants
|
572 participants
n=5 Participants
|
|
Region of Enrollment
Uruguay
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Venezuela
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Hormonal Receptor Status
Positive
|
1348 Participants
n=5 Participants
|
1346 Participants
n=7 Participants
|
2694 Participants
n=5 Participants
|
|
Hormonal Receptor Status
Negative
|
301 Participants
n=5 Participants
|
303 Participants
n=7 Participants
|
604 Participants
n=5 Participants
|
|
Karnofsky Performance Status at Baseline
80 - Activity with effort; some signs of disease
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Karnofsky Performance Status at Baseline
90 - Normal activity; minor signs of disease
|
315 Participants
n=5 Participants
|
323 Participants
n=7 Participants
|
638 Participants
n=5 Participants
|
|
Karnofsky Performance Status at Baseline
100 - Normal no complaints; no evidence of disease
|
1298 Participants
n=5 Participants
|
1293 Participants
n=7 Participants
|
2591 Participants
n=5 Participants
|
|
Menopausal status
Pre-Menopausal or Other age < 50 Years
|
866 Participants
n=5 Participants
|
863 Participants
n=7 Participants
|
1729 Participants
n=5 Participants
|
|
Menopausal status
Post-Menopausal or Other age > 50 Years
|
783 Participants
n=5 Participants
|
786 Participants
n=7 Participants
|
1569 Participants
n=5 Participants
|
|
Number of Positive Lymph Nodes
[0]
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Number of Positive Lymph Nodes
[1 to 3]
|
1010 Participants
n=5 Participants
|
1005 Participants
n=7 Participants
|
2015 Participants
n=5 Participants
|
|
Number of Positive Lymph Nodes
[4 to 10]
|
462 Participants
n=5 Participants
|
456 Participants
n=7 Participants
|
918 Participants
n=5 Participants
|
|
Number of Positive Lymph Nodes
> 10
|
177 Participants
n=5 Participants
|
187 Participants
n=7 Participants
|
364 Participants
n=5 Participants
|
|
Patients with at least one surgery
Mastectomy
|
955 Participants
n=5 Participants
|
973 Participants
n=7 Participants
|
1928 Participants
n=5 Participants
|
|
Patients with at least one surgery
Lumpectomy
|
283 Participants
n=5 Participants
|
276 Participants
n=7 Participants
|
559 Participants
n=5 Participants
|
|
Patients with at least one surgery
Quadrantectomy/Segmental
|
411 Participants
n=5 Participants
|
400 Participants
n=7 Participants
|
811 Participants
n=5 Participants
|
|
Primary Tumor
pT1: Tumor < = 2cm
|
692 Participants
n=5 Participants
|
668 Participants
n=7 Participants
|
1360 Participants
n=5 Participants
|
|
Primary Tumor
pT2: Tumor in [ 2 - 5 ]
|
824 Participants
n=5 Participants
|
844 Participants
n=7 Participants
|
1668 Participants
n=5 Participants
|
|
Primary Tumor
pT3: Tumor > 5cm
|
131 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
266 Participants
n=5 Participants
|
|
Primary Tumor
pT4: Tumor with extension to chest wall/skin
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Primary Tumor
pTis: Carcinoma in situ
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median follow-up 65 monthsPopulation: The primary efficacy analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median disease free survival time, median time-to-event was not reached in any group; therefore, number of participants with relapse was presented.
The primary event is the local, regional or metastatic relapse or the date of second primary cancer or death from any cause (whichever occurs first). The primary efficacy analysis is performed on the time from randomization to this primary event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Outcome measures
| Measure |
Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)
n=1649 Participants
AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
|
Docetaxel + Doxorubicin and Cyclophosphamide (TAC)
n=1649 Participants
TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
|
|---|---|---|
|
Local, Regional or Metastatic Relapse, or Second Primary Cancer, or Death From Any Cause (Disease-Free Survival)
|
356 Participants
|
352 Participants
|
SECONDARY outcome
Timeframe: Median follow-up of 65 monthsPopulation: The analysis was performed on the Intent-to-Treat (ITT) population. Although the original Outcome Measure was intended to be presented as median survival time, median time-to-event was not reached in any group; therefore, number of participants who died was presented.
The considered event is death from any cause. The analysis is performed on the time from randomization to this event. The Measured Values table below presents the numbers of patients with the event at the end of the study period.
Outcome measures
| Measure |
Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)
n=1649 Participants
AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
|
Docetaxel + Doxorubicin and Cyclophosphamide (TAC)
n=1649 Participants
TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
|
|---|---|---|
|
Death From Any Cause (Overall Survival)
|
187 Participants
Interval 65.64 to 65.91
|
202 Participants
Interval 65.48 to 65.84
|
Adverse Events
Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)
Serious events: 331 serious events
Other events: 1634 other events
Deaths: 0 deaths
Docetaxel + Doxorubicin and Cyclophosphamide (TAC)
Serious events: 520 serious events
Other events: 1629 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)
n=1634 participants at risk
AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
|
Docetaxel + Doxorubicin and Cyclophosphamide (TAC)
n=1635 participants at risk
TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
|
|---|---|---|
|
General disorders
Abdominal Syndrom Acute
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Allergic Reaction
|
0.43%
7/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.31%
5/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.18%
3/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
0.18%
3/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.31%
5/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Anorexia
|
0.12%
2/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Arrhythmia
|
0.18%
3/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.18%
3/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Arrhythmia Ventricular
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Vascular disorders
Arteriosclerosis
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.18%
3/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthrosis
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Asthenia
|
0.31%
5/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.31%
5/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Cardiomyopathy
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Cellulitis
|
0.37%
6/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Vascular disorders
Cerebrovascular Accident
|
0.12%
2/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.24%
4/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Coagulation disorders
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Colitis
|
0.12%
2/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.31%
5/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Constipation
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.49%
8/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Convulsion
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Renal and urinary disorders
Creatinine increase
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cyst
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Renal and urinary disorders
Cystitis
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Ear and labyrinth disorders
Deaf
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Dehydration
|
0.49%
8/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.37%
6/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Delusions
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Depression
|
0.12%
2/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Derm Exfoliating
|
0.49%
8/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
0.80%
13/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.80%
13/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.18%
3/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.31%
5/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.18%
3/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Edema
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Edema Peripheral
|
0.31%
5/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Effusion Pericardial
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Effusion Pleural
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Emotional Lability
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Encephalopathy
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Erythema Multiform
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Fever (including serious febrile neutropenia)
|
7.5%
122/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
17.9%
293/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Fibrillation Ventricular
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Fibrosis lung
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Gastritis
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Gastro-intestinal Disorder
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Gastroenteritis
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Headache
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Heart Arrest
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Heart Failure Left
|
0.18%
3/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Vascular disorders
Hemorrhage Intracranial
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Hemorrhage Rectal
|
0.12%
2/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Eye disorders
Hemorrhage Retinal
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Hemorrhage Vaginal
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Herpes Zoster
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Hydrocephalus
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.12%
2/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Endocrine disorders
Hyperthyroidism
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Hypotension
|
0.24%
4/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.18%
3/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Ileus
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Infections and infestations
Infection (including neutropenic infection)
|
5.3%
86/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
8.7%
143/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Injury, poisoning and procedural complications
Injury Accident
|
0.18%
3/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Ischemia myocardial
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Renal and urinary disorders
Kidney Failure
|
0.12%
2/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.1%
18/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
3.4%
56/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Hepatobiliary disorders
Liver Failure
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Lung Disorder
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Lymphedema
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Renal and urinary disorders
Mastitis
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Reproductive system and breast disorders
Menstrual Disorder
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Mucous Membrane Disorder
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.24%
4/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.18%
3/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Nail Disorder
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Nausea
|
0.86%
14/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
1.2%
19/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Uterine
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Neuropathy
|
0.37%
6/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.18%
3/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodule skin
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Pain
|
0.18%
3/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Pain Abdominal
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.18%
3/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Pain Biliary
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Pain Chest
|
0.18%
3/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.18%
3/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Eye disorders
Papilledema
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Paralysis Vocal Cord
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Peritonitis
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia Interstitial
|
0.12%
2/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy Unintended
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.12%
2/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Proctitis
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Psychiatric disorders
Psychosis
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Rash Maculopapular
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Hepatobiliary disorders
SGOT Increase
|
0.12%
2/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Hepatobiliary disorders
SGPT Increase
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Stomatitis
|
0.49%
8/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.55%
9/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Syncope
|
0.49%
8/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.31%
5/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Tachycardia
|
0.24%
4/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Vascular disorders
Thrombophlebitis Deep
|
0.86%
14/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.86%
14/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Ear and labyrinth disorders
Tinnitus
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Ulcer Stomach
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Renal and urinary disorders
Urinary Tract Disorder
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Reproductive system and breast disorders
Uterine Fibroid Enlargement
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Reproductive system and breast disorders
Vaginitis
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Vertigo
|
0.00%
0/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.06%
1/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
16/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
1.7%
28/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Reproductive system and breast disorders
Vulvovaginitis
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Weight Increase
|
0.06%
1/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
0.00%
0/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
Other adverse events
| Measure |
Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)
n=1634 participants at risk
AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
|
Docetaxel + Doxorubicin and Cyclophosphamide (TAC)
n=1635 participants at risk
TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
|
|---|---|---|
|
General disorders
Allergic reaction
|
10.5%
172/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
11.6%
190/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
98.0%
1601/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
97.1%
1587/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Anemia
|
28.2%
461/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
40.2%
658/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Anorexia
|
22.6%
370/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
23.0%
376/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
36.8%
602/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
23.4%
382/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Asthenia
|
81.3%
1328/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
80.1%
1310/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Eye disorders
Conjunctivitis
|
10.8%
176/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
8.0%
131/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Constipation
|
36.7%
599/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
33.9%
555/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.9%
211/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
13.6%
222/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Depression
|
9.8%
160/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
8.1%
132/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Derm exfoliating
|
8.8%
143/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
2.2%
36/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Diarrhea
|
39.4%
644/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
37.1%
606/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Dizziness
|
9.1%
149/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
10.3%
169/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Eye disorders
Dry eye
|
5.3%
87/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
4.0%
65/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Dry mouth
|
9.1%
149/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
4.9%
80/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Dyspepsia
|
20.7%
339/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
23.7%
387/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Dysphagia
|
5.1%
83/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
4.0%
65/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
19.5%
319/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
17.6%
287/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Metabolism and nutrition disorders
Edema peripheral
|
29.9%
488/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
25.5%
417/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Emotion labil
|
10.3%
168/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
6.8%
111/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Epistaxis
|
7.5%
123/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
4.4%
72/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Fever (including febrile neutropenia)
|
17.7%
289/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
28.6%
467/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Headache
|
26.5%
433/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
22.6%
370/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Infections and infestations
Infection (including neutropenic infection)
|
35.1%
573/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
28.0%
457/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Injection site reaction
|
7.6%
124/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
5.6%
92/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Insomnia
|
20.4%
334/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
16.9%
277/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Eye disorders
Lacrimation disorder
|
21.8%
357/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
13.0%
212/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Leucopenia
|
3.6%
59/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
5.4%
88/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Lymphedema
|
6.2%
101/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
6.7%
109/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Reproductive system and breast disorders
Menses disorder
|
29.9%
489/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
30.6%
501/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
51.0%
834/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
35.9%
587/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
44.6%
729/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
22.2%
363/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Nausea
|
87.8%
1435/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
81.6%
1334/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Neuropathy
|
44.2%
723/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
29.5%
482/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Neutropenia
|
69.3%
1133/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
64.2%
1049/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Pain
|
16.8%
275/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
14.4%
235/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Pain abdominal
|
15.7%
256/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
16.6%
271/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Pain back
|
7.5%
123/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
7.4%
121/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Pain bone
|
14.1%
230/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
12.5%
204/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Pain chest
|
5.7%
93/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
4.6%
76/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Cardiac disorders
Palpitations
|
5.0%
82/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
5.1%
84/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
5.4%
88/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
4.2%
69/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Proctitis
|
5.0%
82/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
6.1%
100/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Rash maculopapular
|
24.6%
402/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
19.2%
314/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis
|
16.4%
268/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
12.1%
198/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Skin dry
|
6.5%
107/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
5.2%
85/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Stomatitis
|
63.3%
1035/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
62.8%
1026/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Skin and subcutaneous tissue disorders
Sweating
|
4.7%
77/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
5.7%
93/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Taste pervers
|
29.4%
480/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
26.1%
426/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.2%
52/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
6.7%
109/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Nervous system disorders
Vasodilatation
|
23.7%
388/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
26.7%
437/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
Gastrointestinal disorders
Vomiting
|
55.5%
907/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
45.4%
742/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Weight decrease
|
7.1%
116/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
8.6%
140/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
|
General disorders
Weight increase
|
22.6%
370/1634
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
14.7%
240/1635
The number of patients at risk corresponds to the patients who received at least one dose of treatment
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If no publication has occurred within 12 months of the completion of the study, the Investigator shall have the right to publish/present independently the results of the study. The Investigator shall provide the Sponsor with a copy of any such presentation/publication for comment at least 30 days before any presentation/submission for publication. If requested by the Sponsor, any presentation/submission shall be delayed up to 90 days, to allow the Sponsor to preserve its proprietary rights.
- Publication restrictions are in place
Restriction type: OTHER