Trial Outcomes & Findings for Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer (NCT NCT00014222)
NCT ID: NCT00014222
Last Updated: 2020-10-05
Results Overview
Disease free survival was defined as the time from randomization to the time of recurrence of the primary disease. Local or nodal recurrence and metastatic disease were considered a recurrence of the primary tumour. Patients who had contralateral breast cancer or a second primary malignancy, or died from some cause other than disease were censored as relapse-free at the time of death. Patients who had not relapsed were censored at longest follow-up or at non-breast cancer death. As required, adjudication was used to assess reports of recurrence.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2104 participants
Primary outcome timeframe
13 years
Results posted on
2020-10-05
Participant Flow
Participant milestones
| Measure |
Arm 1: CEF
6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid
cyclophosphamide: 75, 600 and 830 mg/m2
epirubicin hydrochloride: 60 mg/m2
fluorouracil: 500mg/m2
|
Arm 2: EC/T
6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
epoetin alfa: 40,000 IU
filgrastim: 5 mg/kg/d - days 2-13
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
Arm 3: AC/T
4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
|---|---|---|---|
|
Overall Study
STARTED
|
701
|
701
|
702
|
|
Overall Study
COMPLETED
|
680
|
688
|
675
|
|
Overall Study
NOT COMPLETED
|
21
|
13
|
27
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Combination Chemotherapy With or Without Colony-stimulating Factors in Treating Women With Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1: CEF
n=700 Participants
6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid
cyclophosphamide: 75, 600 and 830 mg/m2
epirubicin hydrochloride: 60 mg/m2
fluorouracil: 500mg/m2
|
Arm 2: EC/T
n=701 Participants
6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
epoetin alfa: 40,000 IU
filgrastim: 5 mg/kg/d - days 2-13
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
Arm 3: AC/T
n=702 Participants
4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
Total
n=2103 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.1 years
n=99 Participants
|
47.6 years
n=107 Participants
|
47.6 years
n=206 Participants
|
47.7 years
n=7 Participants
|
|
Sex: Female, Male
Female
|
700 Participants
n=99 Participants
|
701 Participants
n=107 Participants
|
702 Participants
n=206 Participants
|
2103 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
11 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
20 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
30 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
74 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
98 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
633 Participants
n=99 Participants
|
624 Participants
n=107 Participants
|
609 Participants
n=206 Participants
|
1866 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
17 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
43 Participants
n=7 Participants
|
|
Performance status
0
|
588 Participants
n=99 Participants
|
588 Participants
n=107 Participants
|
590 Participants
n=206 Participants
|
1766 Participants
n=7 Participants
|
|
Performance status
1
|
109 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
109 Participants
n=206 Participants
|
331 Participants
n=7 Participants
|
|
Performance status
2
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 13 yearsPopulation: Intent to treat population was used for this analysis,.
Disease free survival was defined as the time from randomization to the time of recurrence of the primary disease. Local or nodal recurrence and metastatic disease were considered a recurrence of the primary tumour. Patients who had contralateral breast cancer or a second primary malignancy, or died from some cause other than disease were censored as relapse-free at the time of death. Patients who had not relapsed were censored at longest follow-up or at non-breast cancer death. As required, adjudication was used to assess reports of recurrence.
Outcome measures
| Measure |
Arm 1: CEF
n=701 Participants
6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid
cyclophosphamide: 75, 600 and 830 mg/m2
epirubicin hydrochloride: 60 mg/m2
fluorouracil: 500mg/m2
|
Arm 2: EC/T
n=701 Participants
6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
epoetin alfa: 40,000 IU
filgrastim: 5 mg/kg/d - days 2-13
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
Arm 3: AC/T
n=702 Participants
4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
|---|---|---|---|
|
Disease Free Survival
Disease Recurrence
|
141 Participants
|
135 Participants
|
191 Participants
|
|
Disease Free Survival
No recurrence
|
560 Participants
|
566 Participants
|
511 Participants
|
SECONDARY outcome
Timeframe: 13 yearsPopulation: Intention to treat population.
Overall survival was defined as the time from randomization to the time of death from any cause, with censoring at longest follow-up.
Outcome measures
| Measure |
Arm 1: CEF
n=701 Participants
6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid
cyclophosphamide: 75, 600 and 830 mg/m2
epirubicin hydrochloride: 60 mg/m2
fluorouracil: 500mg/m2
|
Arm 2: EC/T
n=701 Participants
6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
epoetin alfa: 40,000 IU
filgrastim: 5 mg/kg/d - days 2-13
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
Arm 3: AC/T
n=702 Participants
4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
|---|---|---|---|
|
Overall Survival
Death
|
123 Participants
|
107 Participants
|
146 Participants
|
|
Overall Survival
Alive
|
578 Participants
|
594 Participants
|
556 Participants
|
Adverse Events
Arm 1: CEF
Serious events: 83 serious events
Other events: 680 other events
Deaths: 123 deaths
Arm 2: EC/T
Serious events: 86 serious events
Other events: 688 other events
Deaths: 107 deaths
Arm 3: AC/T
Serious events: 23 serious events
Other events: 673 other events
Deaths: 146 deaths
Serious adverse events
| Measure |
Arm 1: CEF
n=680 participants at risk
6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid
cyclophosphamide: 75, 600 and 830 mg/m2
epirubicin hydrochloride: 60 mg/m2
fluorouracil: 500mg/m2
|
Arm 2: EC/T
n=688 participants at risk
6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
epoetin alfa: 40,000 IU
filgrastim: 5 mg/kg/d - days 2-13
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
Arm 3: AC/T
n=675 participants at risk
4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Hemoglobin
|
1.6%
11/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
2.2%
15/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Blood and lymphatic system disorders
Transfusion: Platelets
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Blood and lymphatic system disorders
Transfusion: pRBCs
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
7.2%
49/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.0%
41/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
1.2%
8/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Cardiac disorders
Edema
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Cardiac disorders
Ischemia/infarction
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.30%
2/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Eye disorders
Keratitis
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Eye disorders
Double vision
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Colitis
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Diarrhea
|
0.88%
6/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.29%
2/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Dysphagia
|
0.88%
6/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.29%
2/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Proctitis
|
0.29%
2/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Stomatitis
|
1.8%
12/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
1.7%
12/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Vomiting
|
0.44%
3/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.73%
5/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.44%
3/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.29%
2/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.30%
2/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
General disorders
Fatigue
|
0.74%
5/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
1.0%
7/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
General disorders
Rigors, chills
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.44%
3/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
General disorders
Chest pain
|
0.29%
2/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
General disorders
Pain-Other
|
0.29%
2/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.29%
2/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
General disorders
Injection site reaction
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.44%
3/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Immune system disorders
Allergic reaction
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Immune system disorders
Other
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.29%
2/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Immune system disorders
Fever
|
0.59%
4/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
1.2%
8/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.30%
2/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Infections and infestations
Catheter-related infect
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Infections and infestations
Wound-infectious
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Investigations
Granulocytes
|
2.6%
18/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
2.3%
16/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.59%
4/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Investigations
Platelets
|
1.5%
10/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
2.0%
14/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Investigations
Leukocytes (total WBC)
|
1.0%
7/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
1.3%
9/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Investigations
Cardiac troponin T
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Investigations
Alkaline phosphatase
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Investigations
SGPT (ALT)
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Investigations
SGOT (AST)
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Investigations
Bilirubin
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.44%
3/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
2/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.44%
3/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Metabolism and nutrition disorders
Mouth dryness
|
0.29%
2/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.29%
2/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
0.59%
4/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.44%
3/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
CNS hemorrhage/bleed
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Ataxia
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Dizziness
|
0.29%
2/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.29%
2/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Neuropathy-motor
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Neuropathy-sensory
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.29%
2/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Seizure(s)
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Vertigo
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Headache
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.44%
3/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Neuropathic pain
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Psychiatric disorders
Anxiety
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Psychiatric disorders
Confusion
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Psychiatric disorders
Depression
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Reproductive system and breast disorders
Vaginitis
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Reproductive system and breast disorders
Vaginal bleeding
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.29%
2/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.29%
2/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.15%
1/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.29%
2/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.58%
4/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.30%
2/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.58%
4/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.29%
2/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.44%
3/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Vascular disorders
Hypotension
|
0.00%
0/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.00%
0/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Vascular disorders
Thrombosis/embolism
|
1.0%
7/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.73%
5/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
0.15%
1/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
Other adverse events
| Measure |
Arm 1: CEF
n=680 participants at risk
6 cycles - q 28 days (6 months) - Cyclophosphamide 75 mg/m2 - po - Days 1-14 - Epirubicin 60 mg/m2 - IV - Days 1 and 8 - 5 Fluorouracil: 500mg/m2 - IV - Days 1 and 8 + Continuous Antibiotic Prophylaxis with Cotrimoxazole 960 mg (i.e.2x480 mg tablets) po-bid or Ciprofloxacin 500 mg - po-bid
cyclophosphamide: 75, 600 and 830 mg/m2
epirubicin hydrochloride: 60 mg/m2
fluorouracil: 500mg/m2
|
Arm 2: EC/T
n=688 participants at risk
6 cycles - q 14 days (3 months) - Epirubicin 120 mg/m2 - IV - Day 1 - Cyclophosphamide 830 mg/m2 - IV - Day 1 - Filgrastim 5μg/kg/d - SC - Days 2 - 13 + Epoetin Alfa 40,000 IU - SC - once weekly (to begin within 1 week after start of protocol therapy as needed) 21 days from last administration of EC (EC/T) 4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 - 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
epoetin alfa: 40,000 IU
filgrastim: 5 mg/kg/d - days 2-13
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
Arm 3: AC/T
n=675 participants at risk
4 cycles - q 21 days (3 months) - Adriamycin 60 mg/m2 - IV - Day 1 - Cyclophosphamide 600 mg/m2 - IV - Day 1 21 days from last administration of AC 4 cycles - q 21 days (3 months) - Paclitaxel 175 mg/m2 IV 3 hour infusion
cyclophosphamide: 75, 600 and 830 mg/m2
doxorubicin hydrochloride: 60 mg/m2
paclitaxel: 175 mg/m2
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphedema
|
4.6%
31/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
3.8%
26/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
7.6%
51/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Cardiac disorders
Edema
|
16.5%
112/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
15.7%
108/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
16.3%
110/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Cardiac disorders
Cardiac LVF
|
27.2%
185/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
21.4%
147/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
19.3%
130/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Cardiac disorders
Palpitations
|
4.3%
29/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.5%
45/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
5.3%
36/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Eye disorders
Blurred vision
|
4.7%
32/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
8.1%
56/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.8%
46/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Eye disorders
Dry eye
|
9.9%
67/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
11.6%
80/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
12.0%
81/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Eye disorders
Tearing
|
17.9%
122/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
27.0%
186/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
21.5%
145/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Constipation
|
61.0%
415/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
64.2%
442/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
58.5%
395/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Diarrhea
|
47.2%
321/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
58.1%
400/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
40.4%
273/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Dysphagia
|
19.9%
135/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
23.7%
163/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
14.5%
98/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Mouth dryness
|
6.5%
44/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
14.7%
101/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
4.7%
32/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Dyspepsia/heartburn
|
40.9%
278/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
35.2%
242/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
30.7%
207/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Nausea
|
85.7%
583/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
92.4%
636/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
89.0%
601/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Proctitis
|
12.1%
82/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
13.8%
95/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
3.9%
26/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Stomatitis
|
81.5%
554/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
80.5%
554/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
63.9%
431/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Vomiting
|
54.3%
369/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
72.5%
499/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
52.3%
353/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Rectal bleeding
|
4.0%
27/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.5%
45/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
1.6%
11/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Abdominal pain
|
11.5%
78/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
13.5%
93/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
14.4%
97/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Gastrointestinal disorders
Rectal/perirectal pain
|
3.7%
25/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
5.1%
35/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
1.6%
11/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
General disorders
Fatigue
|
94.6%
643/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
94.3%
649/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
92.0%
621/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
General disorders
Rigors, chills
|
8.2%
56/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
9.7%
67/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.2%
42/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
General disorders
Chest pain
|
5.4%
37/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
7.4%
51/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
5.3%
36/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
General disorders
Pain-Other
|
22.2%
151/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
28.8%
198/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
25.3%
171/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
General disorders
Injection site reaction
|
19.1%
130/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
23.5%
162/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
10.4%
70/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Immune system disorders
Fever
|
15.6%
106/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
24.7%
170/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
11.7%
79/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Infections and infestations
Infection w/o neutropen
|
26.6%
181/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
34.0%
234/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
24.0%
162/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Infections and infestations
Febrile neutropenia
|
22.9%
156/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
16.4%
113/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
4.6%
31/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Infections and infestations
Wound-infectious
|
3.5%
24/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.8%
47/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
4.4%
30/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Investigations
Weight loss
|
2.5%
17/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
9.9%
68/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
1.0%
7/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Metabolism and nutrition disorders
Anorexia
|
47.5%
323/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
62.6%
431/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
43.9%
296/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
38/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
8.1%
56/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
3.7%
25/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
4.6%
31/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
8.3%
57/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
7.1%
48/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
35.4%
241/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
72.2%
497/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
67.7%
457/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
38.5%
262/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
75.7%
521/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
74.1%
500/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
14.7%
100/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
34.2%
235/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
18.1%
122/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Taste disturbance
|
30.1%
205/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
39.1%
269/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
29.9%
202/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Dizziness
|
32.1%
218/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
38.5%
265/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
27.4%
185/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Memory loss
|
3.1%
21/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
4.7%
32/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.5%
44/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Neuropathy-motor
|
4.3%
29/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
9.2%
63/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.5%
44/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Neuropathy-sensory
|
26.3%
179/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
72.5%
499/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
70.2%
474/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Headache
|
33.7%
229/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
44.8%
308/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
39.4%
266/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Nervous system disorders
Neuropathic pain
|
2.9%
20/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
7.3%
50/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.5%
44/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Psychiatric disorders
Anxiety
|
17.2%
117/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
21.9%
151/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
23.1%
156/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Psychiatric disorders
Insomnia
|
26.6%
181/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
31.7%
218/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
29.5%
199/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Psychiatric disorders
Depression
|
14.7%
100/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
18.8%
129/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
15.0%
101/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Renal and urinary disorders
Urine frequency/urgency
|
4.7%
32/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
5.7%
39/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
4.0%
27/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Reproductive system and breast disorders
Vaginitis
|
7.2%
49/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
8.1%
56/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
5.6%
38/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Reproductive system and breast disorders
Irregular menses
|
42.6%
290/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
51.2%
352/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
39.9%
269/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Reproductive system and breast disorders
Vaginal dryness
|
6.6%
45/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
7.6%
52/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
5.3%
36/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
15.3%
104/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
29.8%
205/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
25.3%
171/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
21.6%
147/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
33.6%
231/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
26.2%
177/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
43.7%
297/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
46.5%
320/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
35.7%
241/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
7.2%
49/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
9.6%
66/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
9.5%
64/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
93.4%
635/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
93.2%
641/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
94.2%
636/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.0%
61/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
12.9%
89/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
8.6%
58/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
3.2%
22/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
15.4%
106/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
3.0%
20/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
15.3%
104/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
45.1%
310/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
14.8%
100/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Pigmentation changes
|
3.4%
23/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
7.6%
52/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
3.3%
22/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.1%
21/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
5.1%
35/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.4%
43/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
23.2%
158/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
29.4%
202/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
23.1%
156/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Skin and subcutaneous tissue disorders
Other
|
4.1%
28/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.8%
47/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
5.6%
38/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Vascular disorders
Phlebitis
|
3.2%
22/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.1%
42/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
1.6%
11/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Vascular disorders
Thrombosis/embolism
|
7.6%
52/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.7%
46/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
1.6%
11/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Vascular disorders
Hot flashes/ flushes
|
64.0%
435/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
67.9%
467/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
69.6%
470/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
|
Vascular disorders
Flushing
|
1.2%
8/680 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
6.5%
45/688 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
7.1%
48/675 • 13 years
Serious and Other Adverse Events were assessed in participants who received protocol treatment. All-cause mortality was collected for all enrolled participants based on intention to treat population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place