Trial Outcomes & Findings for Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer (NCT NCT00093795)
NCT ID: NCT00093795
Last Updated: 2018-01-11
Results Overview
The percentage of patients alive and cancer-free.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
4894 participants
Primary outcome timeframe
5 years
Results posted on
2018-01-11
Participant Flow
Participant milestones
| Measure |
Group 1: TAC X 6
Doxorubicin, cyclophosphamide, and docetaxel.
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 2: AC X 4 Then P X 4
Doxorubicin, cyclophosphamide, and paclitaxel
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 3: AC X 4 Then PG X 4
Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
|---|---|---|---|
|
Overall Study
STARTED
|
1630
|
1634
|
1630
|
|
Overall Study
COMPLETED
|
1610
|
1618
|
1613
|
|
Overall Study
NOT COMPLETED
|
20
|
16
|
17
|
Reasons for withdrawal
| Measure |
Group 1: TAC X 6
Doxorubicin, cyclophosphamide, and docetaxel.
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 2: AC X 4 Then P X 4
Doxorubicin, cyclophosphamide, and paclitaxel
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 3: AC X 4 Then PG X 4
Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
|---|---|---|---|
|
Overall Study
No follow up data
|
20
|
16
|
17
|
Baseline Characteristics
Combination Chemotherapy in Treating Women Who Have Undergone Surgery for Node-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
TAC X 6
n=1623 Participants
Doxorubicin, cyclophosphamide, and docetaxel. Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
AC X 4 Then P X 4
n=1623 Participants
Doxorubicin, cyclophosphamide, and paclitaxel Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
AC X 4 Then PG X 4
n=1621 Participants
Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Total
n=4867 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 9.5 • n=5 Participants
|
51 years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
51 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
51 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
1623 Participants
n=5 Participants
|
1623 Participants
n=7 Participants
|
1621 Participants
n=5 Participants
|
4867 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: 5 yearsPopulation: For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants.
The percentage of patients alive and cancer-free.
Outcome measures
| Measure |
Group 1: TAC X 6
n=1610 Participants
Doxorubicin, cyclophosphamide, and docetaxel.
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 2: AC X 4 Then P X 4
n=1618 Participants
Doxorubicin, cyclophosphamide, and paclitaxel
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 3: AC X 4 Then PG X 4
n=1613 Participants
Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
|---|---|---|---|
|
Disease-free Survival: Any Recurrence, Contralateral Breast Cancer, Second Primary Cancer, Death From Any Cause Prior to Recurrence or Second Primary Cancer
|
80.1 percentage of patients
Interval 78.0 to 82.0
|
82.2 percentage of patients
Interval 80.2 to 84.0
|
80.6 percentage of patients
Interval 78.5 to 82.5
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: For Arm 1 there is no follow-up data for 13 participants; for Arm 2 there is no follow-up data for 10 participants; and for Arm 3 there is no follow-up data for 12 participants.
Percentage of participants alive at 5 years
Outcome measures
| Measure |
Group 1: TAC X 6
n=1617 Participants
Doxorubicin, cyclophosphamide, and docetaxel.
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 2: AC X 4 Then P X 4
n=1624 Participants
Doxorubicin, cyclophosphamide, and paclitaxel
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 3: AC X 4 Then PG X 4
n=1618 Participants
Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
|---|---|---|---|
|
Overall Survival
|
89.6 percentage of patients alive
Interval 88.1 to 91.1
|
89.1 percentage of patients alive
Interval 87.4 to 90.5
|
90.8 percentage of patients alive
Interval 89.3 to 92.1
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants.
Percentage of patients recurrence-free (no first local, regional, or distant recurrence)
Outcome measures
| Measure |
Group 1: TAC X 6
n=1610 Participants
Doxorubicin, cyclophosphamide, and docetaxel.
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 2: AC X 4 Then P X 4
n=1618 Participants
Doxorubicin, cyclophosphamide, and paclitaxel
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 3: AC X 4 Then PG X 4
n=1613 Participants
Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
|---|---|---|---|
|
Recurrence-free Interval: Time to First Local, Regional, or Distant Recurrence
|
85.1 percentage of patients
Interval 83.2 to 86.9
|
86.2 percentage of patients
Interval 84.3 to 87.9
|
84.8 percentage of patients
Interval 82.8 to 86.5
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: For Arm 1 there is no follow-up data for 20 participants; for Arm 2 there is no follow-up data for 16 participants; and for Arm 3 there is no follow-up data for 17 participants.
Percentage of patients distant recurrence-free (no distant disease recurrence only)
Outcome measures
| Measure |
Group 1: TAC X 6
n=1610 Participants
Doxorubicin, cyclophosphamide, and docetaxel.
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 2: AC X 4 Then P X 4
n=1618 Participants
Doxorubicin, cyclophosphamide, and paclitaxel
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 3: AC X 4 Then PG X 4
n=1613 Participants
Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
|---|---|---|---|
|
Distant Recurrence-free Interval: the Time to Distant Disease Recurrence Only
|
86.6 percentage of patients
Interval 84.7 to 88.2
|
87.4 percentage of patients
Interval 85.6 to 89.0
|
86.6 percentage of patients
Interval 84.7 to 88.2
|
SECONDARY outcome
Timeframe: 30 days after the last dose of study therapy (about 7 months after study entry)Population: For Arm 1 there is no follow-up data for 23 participants; for Arm 2 there is no follow-up data for 11 participants; and for Arm 3 there is not follow-up data for 18 participants.
Percentage of patients who ever experienced grade 2 or higher toxicities.
Outcome measures
| Measure |
Group 1: TAC X 6
n=1607 Participants
Doxorubicin, cyclophosphamide, and docetaxel.
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Docetaxel: 75 mg/m2 IV every 21 days for 6 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 2: AC X 4 Then P X 4
n=1623 Participants
Doxorubicin, cyclophosphamide, and paclitaxel
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
Group 3: AC X 4 Then PG X 4
n=1612 Participants
Doxorubicin, cyclophosphamide, paclitaxel and gemcitabine
Cyclophosphamide: Group 1: cyclophosphamide 500 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: cyclophosphamide 600 mg/m2 IV every 14 days for 4 cycles
Gemcitabine: 2000 mg/m2 IV every 14 days for 4 cycles
Paclitaxel: 175 mg/m2 IV every 14 days for 4 cycles
Doxorubicin: Group 1: 50 mg/m2 IV every 21 days for 6 cycles
Group 2 and Group 3: 60 mg/m2 IV every 14 days for 4 cycles
|
|---|---|---|---|
|
Toxicity
|
82.7 percentage of patients
Interval 80.8 to 84.5
|
87.5 percentage of patients
Interval 85.8 to 89.0
|
88.4 percentage of patients
Interval 86.7 to 89.9
|
Adverse Events
TAC X 6
Serious events: 277 serious events
Other events: 1231 other events
Deaths: 0 deaths
AC X 4 Then P X 4
Serious events: 158 serious events
Other events: 1322 other events
Deaths: 0 deaths
AC X 4 Then PG X 4
Serious events: 187 serious events
Other events: 1323 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TAC X 6
n=1601 participants at risk
TAC X 6
|
AC X 4 Then P X 4
n=1612 participants at risk
AC X 4 then P X 4
|
AC X 4 Then PG X 4
n=1604 participants at risk
AC X 4 then PG X 4
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.3%
21/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.50%
8/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.81%
13/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.25%
4/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Alanine aminotransferase increased (ALT/SGPT)
|
0.25%
4/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.43%
7/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.31%
5/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.19%
3/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.25%
4/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Anxiety
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Aspartate aminotransferase increased (AST/SGOT)
|
0.31%
5/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.37%
6/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.25%
4/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Atrial fibrillation
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.19%
3/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Bladder infection
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.62%
10/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.74%
12/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.56%
9/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Cardiac troponin I increased
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Colitis
|
0.56%
9/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Colonic fistula
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Colonic perforation
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Confusion
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Constipation
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.19%
3/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.31%
5/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.19%
3/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Creatinine increased
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
22/1601
Participants at Risk includes any patient who submitted an AE form.
|
2.6%
42/1612
Participants at Risk includes any patient who submitted an AE form.
|
1.4%
23/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Depression
|
0.25%
4/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.25%
4/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Diarrhea
|
0.56%
9/1601
Participants at Risk includes any patient who submitted an AE form.
|
1.1%
17/1612
Participants at Risk includes any patient who submitted an AE form.
|
2.9%
47/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Dizziness
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Dysphagia
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.2%
19/1601
Participants at Risk includes any patient who submitted an AE form.
|
1.4%
23/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.87%
14/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Encephalopathy
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Esophageal ulcer
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Esophagitis
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Fatigue
|
2.7%
43/1601
Participants at Risk includes any patient who submitted an AE form.
|
2.3%
37/1612
Participants at Risk includes any patient who submitted an AE form.
|
1.7%
27/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.5%
40/1601
Participants at Risk includes any patient who submitted an AE form.
|
2.8%
45/1612
Participants at Risk includes any patient who submitted an AE form.
|
8.2%
132/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Fever
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.62%
10/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.19%
3/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Flushing
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.25%
4/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Gastritis
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Eye disorders
Glaucoma
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Headache
|
0.25%
4/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.19%
3/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.37%
6/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Hematoma
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Hot flashes
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Hypertension
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Vascular disorders
Hypotension
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.31%
5/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.44%
7/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.44%
7/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.62%
10/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.62%
10/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Ileus
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Injection site reaction
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
INR increased
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Insomnia
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Intracranial hemorrhage
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Ischemia cerebrovascular
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Lipase increased
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Lymphocyte count decreased
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.19%
3/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Mucositis oral
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.25%
4/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.62%
10/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.94%
15/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.56%
9/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.62%
10/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Nausea
|
1.6%
26/1601
Participants at Risk includes any patient who submitted an AE form.
|
2.2%
35/1612
Participants at Risk includes any patient who submitted an AE form.
|
1.1%
18/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Neuralgia
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Neutrophil count decreased
|
1.2%
20/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.31%
5/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.31%
5/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Pericardial effusion
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Pericarditis
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.50%
8/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.62%
10/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.56%
9/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Platelet count decreased
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.62%
10/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.99%
16/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.37%
6/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Proctitis
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Psychiatric disorders
Psychosis
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Rectal hemorrhage
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Rectal pain
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Seizure
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Sinus tachycardia
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Skin infection
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.12%
2/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Syncope
|
0.62%
10/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.37%
6/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.50%
8/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Typhlitis
|
0.19%
3/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Vomiting
|
1.4%
22/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.87%
14/1612
Participants at Risk includes any patient who submitted an AE form.
|
1.4%
23/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Weight loss
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Wound infection
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Edema limbs
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.12%
2/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Glucose intolerance
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.19%
3/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Immune system disorders
Autoimmune disorder
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.06%
1/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.19%
3/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Localized edema
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Infections and infestations
Gallbladder infection
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness left-sided
|
0.06%
1/1601
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1612
Participants at Risk includes any patient who submitted an AE form.
|
0.00%
0/1604
Participants at Risk includes any patient who submitted an AE form.
|
Other adverse events
| Measure |
TAC X 6
n=1601 participants at risk
TAC X 6
|
AC X 4 Then P X 4
n=1612 participants at risk
AC X 4 then P X 4
|
AC X 4 Then PG X 4
n=1604 participants at risk
AC X 4 then PG X 4
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
5.8%
93/1601
Participants at Risk includes any patient who submitted an AE form.
|
4.2%
67/1612
Participants at Risk includes any patient who submitted an AE form.
|
5.4%
87/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Investigations
Alanine aminotransferase increased (ALT/SGPT)
|
1.7%
27/1601
Participants at Risk includes any patient who submitted an AE form.
|
4.5%
73/1612
Participants at Risk includes any patient who submitted an AE form.
|
6.7%
108/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
16.7%
267/1601
Participants at Risk includes any patient who submitted an AE form.
|
30.0%
484/1612
Participants at Risk includes any patient who submitted an AE form.
|
27.8%
446/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Constipation
|
9.6%
154/1601
Participants at Risk includes any patient who submitted an AE form.
|
12.7%
204/1612
Participants at Risk includes any patient who submitted an AE form.
|
11.5%
184/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.0%
64/1601
Participants at Risk includes any patient who submitted an AE form.
|
5.1%
82/1612
Participants at Risk includes any patient who submitted an AE form.
|
5.2%
83/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.6%
137/1601
Participants at Risk includes any patient who submitted an AE form.
|
5.4%
87/1612
Participants at Risk includes any patient who submitted an AE form.
|
5.9%
94/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Diarrhea
|
20.3%
325/1601
Participants at Risk includes any patient who submitted an AE form.
|
9.9%
159/1612
Participants at Risk includes any patient who submitted an AE form.
|
11.5%
185/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
6.9%
110/1601
Participants at Risk includes any patient who submitted an AE form.
|
8.4%
136/1612
Participants at Risk includes any patient who submitted an AE form.
|
7.7%
124/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Fatigue
|
50.3%
805/1601
Participants at Risk includes any patient who submitted an AE form.
|
48.6%
784/1612
Participants at Risk includes any patient who submitted an AE form.
|
48.3%
774/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
9.0%
144/1601
Participants at Risk includes any patient who submitted an AE form.
|
3.1%
50/1612
Participants at Risk includes any patient who submitted an AE form.
|
3.1%
50/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
General disorders
Fever
|
5.7%
91/1601
Participants at Risk includes any patient who submitted an AE form.
|
3.9%
63/1612
Participants at Risk includes any patient who submitted an AE form.
|
4.3%
69/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Headache
|
8.9%
142/1601
Participants at Risk includes any patient who submitted an AE form.
|
11.3%
182/1612
Participants at Risk includes any patient who submitted an AE form.
|
11.7%
188/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Mucositis oral
|
10.8%
173/1601
Participants at Risk includes any patient who submitted an AE form.
|
9.7%
157/1612
Participants at Risk includes any patient who submitted an AE form.
|
12.5%
201/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
16.0%
256/1601
Participants at Risk includes any patient who submitted an AE form.
|
33.3%
536/1612
Participants at Risk includes any patient who submitted an AE form.
|
31.9%
512/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Nausea
|
31.9%
510/1601
Participants at Risk includes any patient who submitted an AE form.
|
31.3%
504/1612
Participants at Risk includes any patient who submitted an AE form.
|
31.0%
497/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.3%
37/1601
Participants at Risk includes any patient who submitted an AE form.
|
5.3%
86/1612
Participants at Risk includes any patient who submitted an AE form.
|
4.7%
76/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
10.4%
167/1601
Participants at Risk includes any patient who submitted an AE form.
|
30.0%
484/1612
Participants at Risk includes any patient who submitted an AE form.
|
26.7%
428/1604
Participants at Risk includes any patient who submitted an AE form.
|
|
Gastrointestinal disorders
Vomiting
|
17.7%
284/1601
Participants at Risk includes any patient who submitted an AE form.
|
15.2%
245/1612
Participants at Risk includes any patient who submitted an AE form.
|
19.1%
306/1604
Participants at Risk includes any patient who submitted an AE form.
|
Additional Information
Director, Department of Regulatory Affairs
NSABP Foundation, Inc
Phone: 412-339-5300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60