Trial Outcomes & Findings for Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy (NCT NCT00110214)
NCT ID: NCT00110214
Last Updated: 2014-05-09
Results Overview
Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1050 participants
Primary outcome timeframe
Duration of study (up to 5 years)
Results posted on
2014-05-09
Participant Flow
Between May 2005 and December 2007, 1,050 participants were recruited and randomized
Participant milestones
| Measure |
Docetaxel + Placebo
Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
|
Docetaxel + Bevacizumab
Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
526
|
524
|
|
Overall Study
COMPLETED
|
17
|
21
|
|
Overall Study
NOT COMPLETED
|
509
|
503
|
Reasons for withdrawal
| Measure |
Docetaxel + Placebo
Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
|
Docetaxel + Bevacizumab
Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
|
|---|---|---|
|
Overall Study
Never started treatment
|
21
|
20
|
|
Overall Study
Disease progression or death
|
260
|
151
|
|
Overall Study
Adverse Event
|
115
|
192
|
|
Overall Study
Refused further treatment
|
52
|
65
|
|
Overall Study
Other (not specified)
|
61
|
75
|
Baseline Characteristics
Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Baseline characteristics by cohort
| Measure |
Docetaxel + Placebo
n=526 Participants
Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
|
Docetaxel + Bevacizumab
n=524 Participants
Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
|
Total
n=1050 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.3 years
n=99 Participants
|
68.8 years
n=107 Participants
|
69.0 years
n=206 Participants
|
|
Age, Customized
< 65 years
|
174 participants
n=99 Participants
|
179 participants
n=107 Participants
|
353 participants
n=206 Participants
|
|
Age, Customized
>=65 years
|
352 participants
n=99 Participants
|
345 participants
n=107 Participants
|
697 participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
526 Participants
n=99 Participants
|
524 Participants
n=107 Participants
|
1050 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
526 participants
n=99 Participants
|
524 participants
n=107 Participants
|
1050 participants
n=206 Participants
|
|
24-month predicted survival probability
<10%
|
95 participants
n=99 Participants
|
94 participants
n=107 Participants
|
189 participants
n=206 Participants
|
|
24-month predicted survival probability
10-29.9%
|
184 participants
n=99 Participants
|
183 participants
n=107 Participants
|
367 participants
n=206 Participants
|
|
24-month predicted survival probability
>=30%
|
247 participants
n=99 Participants
|
247 participants
n=107 Participants
|
494 participants
n=206 Participants
|
|
Prior history of arterial events
Yes
|
42 participants
n=99 Participants
|
37 participants
n=107 Participants
|
79 participants
n=206 Participants
|
|
Prior history of arterial events
No
|
484 participants
n=99 Participants
|
487 participants
n=107 Participants
|
971 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Duration of study (up to 5 years)Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.
Outcome measures
| Measure |
Docetaxel + Placebo
n=526 Participants
Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
|
Docetaxel + Bevacizumab
n=524 Participants
Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
|
|---|---|---|
|
Overall Survival
|
21.5 months
Interval 20.0 to 23.0
|
22.6 months
Interval 21.1 to 24.5
|
SECONDARY outcome
Timeframe: Duration of study (up to 5 years)PSA decline will be reported on all patients and will be defined as a decrease in PSA value by \>= 50% for two successive evaluations at least 4 weeks apart. The reference PSA value for these declines should be measured within 2 weeks before starting therapy.
Outcome measures
| Measure |
Docetaxel + Placebo
n=526 Participants
Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
|
Docetaxel + Bevacizumab
n=524 Participants
Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
|
|---|---|---|
|
Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline
|
57.9 percentage of participants
|
69.5 percentage of participants
|
SECONDARY outcome
Timeframe: Duration of study (up to 5 years)PFS was defined as the data of randomization to date of progression or death due to any cause, whichever occurs first. PFS was estimated using the Kaplan Meier method. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Outcome measures
| Measure |
Docetaxel + Placebo
n=526 Participants
Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
|
Docetaxel + Bevacizumab
n=524 Participants
Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
|
|---|---|---|
|
Progression-free Survival (PFS)
|
7.5 months
Interval 6.8 to 8.0
|
9.9 months
Interval 9.0 to 10.6
|
SECONDARY outcome
Timeframe: During treatment (up to 2 years)Population: Participants who did not received allocated intervention were excluded from toxicity analysis.
The National Cancer Institute (NCI) Criteria for Adverse Events(CTCAE) Version 3.0 was used to evaluate toxicity. These events were considered at least possibly related to treatment. Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death
Outcome measures
| Measure |
Docetaxel + Placebo
n=505 Participants
Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
|
Docetaxel + Bevacizumab
n=504 Participants
Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
|
|---|---|---|
|
Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities
|
56.2 percentage of participants
|
75.4 percentage of participants
|
Adverse Events
Docetaxel + Placebo
Serious events: 237 serious events
Other events: 420 other events
Deaths: 0 deaths
Docetaxel + Bevacizumab
Serious events: 178 serious events
Other events: 363 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Docetaxel + Placebo
n=505 participants at risk
Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
|
Docetaxel + Bevacizumab
n=504 participants at risk
Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.0%
25/505 • Number of events 26
Participants who did not received allocated intervention were excluded from toxicity analysis
|
3.8%
19/504 • Number of events 21
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Blood and lymphatic system disorders
Hemoglobin
|
3.4%
17/505 • Number of events 19
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.8%
14/504 • Number of events 15
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Cardiac General - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
2.4%
12/505 • Number of events 12
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.79%
4/504 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Cardiopulmonary arrest cause unknown (non-fatal)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Conduction abnormality/atrioventricular heart block
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Left ventricular diastolic dysfunction
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
1.6%
8/505 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.0%
10/504 • Number of events 11
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Endocrine disorders
Thyroid function high (hyperthyroidism thyrotoxicosis)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Eye disorders
Ocular/Visual - Other
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Eye disorders
Vision-blurred vision
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Eye disorders
Watery eye (epiphora tearing)
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Colitis
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Constipation
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Diarrhea
|
2.6%
13/505 • Number of events 13
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.8%
9/504 • Number of events 10
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Enteritis (inflammation of the small bowel)
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Esophagitis
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Fistula, GI
|
1.2%
6/505 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.79%
4/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
7.5%
38/505 • Number of events 42
Participants who did not received allocated intervention were excluded from toxicity analysis
|
3.6%
18/504 • Number of events 19
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
1.6%
8/505 • Number of events 9
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Nausea
|
3.2%
16/505 • Number of events 18
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Obstruction GI
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Perforation, GI
|
3.8%
19/505 • Number of events 20
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Ulcer GI
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Ulcer, GI
|
0.79%
4/505 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
10/505 • Number of events 10
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.79%
4/504 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Death not associated with CTCAE term
|
2.0%
10/505 • Number of events 10
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.0%
10/504 • Number of events 10
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Edema: limb
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
7.7%
39/505 • Number of events 46
Participants who did not received allocated intervention were excluded from toxicity analysis
|
4.4%
22/504 • Number of events 27
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Fever
|
8.5%
43/505 • Number of events 47
Participants who did not received allocated intervention were excluded from toxicity analysis
|
6.3%
32/504 • Number of events 35
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Injection site reaction/extravasation changes
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Pain - Other
|
0.99%
5/505 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Rigors/chills
|
2.6%
13/505 • Number of events 15
Participants who did not received allocated intervention were excluded from toxicity analysis
|
3.4%
17/504 • Number of events 20
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Hepatobiliary disorders
Cholecystitis
|
0.59%
3/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Hepatobiliary disorders
Necrosis GI
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Hepatobiliary disorders
Necrosis, GI
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Hepatobiliary disorders
Obstruction, GI
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
0.59%
3/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.59%
3/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Infection
|
6.9%
35/505 • Number of events 41
Participants who did not received allocated intervention were excluded from toxicity analysis
|
5.4%
27/504 • Number of events 30
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Infection - Other
|
2.8%
14/505 • Number of events 14
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.79%
4/504 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
3.6%
18/505 • Number of events 19
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.2%
11/504 • Number of events 15
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Infection with unknown ANC
|
2.6%
13/505 • Number of events 13
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Infection without neutropenia
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Opportunistic infection associated with >=Grade 2 Lymphopenia
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Injury, poisoning and procedural complications
Fracture
|
0.79%
4/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Injury, poisoning and procedural complications
Thrombosis/embolism (vascular access-related)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Injury, poisoning and procedural complications
Wound complication non-infectious
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Alkaline phosphatase
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Cardiac troponin I (cTnI)
|
0.79%
4/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Cardiac troponin T (cTnT)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Coagulation - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Creatinine
|
0.40%
2/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Fibrinogen
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Leukocytes (total WBC)
|
7.7%
39/505 • Number of events 48
Participants who did not received allocated intervention were excluded from toxicity analysis
|
5.0%
25/504 • Number of events 28
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Lymphopenia
|
2.2%
11/505 • Number of events 14
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.2%
11/504 • Number of events 14
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Metabolic/Laboratory - Other
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
13.3%
67/505 • Number of events 79
Participants who did not received allocated intervention were excluded from toxicity analysis
|
9.1%
46/504 • Number of events 58
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC) for BMT studies if specified in the protocol.
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Platelets
|
0.40%
2/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Weight gain
|
0.20%
1/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Weight loss
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
0.79%
4/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Anorexia
|
2.8%
14/505 • Number of events 15
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Calcium serum-high (hypercalcemia)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Calcium serum-low (hypocalcemia)
|
0.99%
5/505 • Number of events 7
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Dehydration
|
5.3%
27/505 • Number of events 32
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.8%
14/504 • Number of events 17
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Glucose serum-high (hyperglycemia)
|
2.2%
11/505 • Number of events 12
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.2%
6/504 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Glucose serum-low (hypoglycemia)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Phosphate serum-low (hypophosphatemia)
|
0.79%
4/505 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.79%
4/504 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Potassium serum-low (hypokalemia)
|
0.79%
4/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
2.0%
10/505 • Number of events 10
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.2%
6/504 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
2.2%
11/505 • Number of events 11
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Musculoskeletal and connective tissue disorders
Trismus (difficulty, restriction or pain when opening mouth)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.99%
5/505 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Cognitive disturbance
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Dizziness
|
0.59%
3/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.4%
7/504 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Encephalopathy
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Hemorrhage CNS
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Neurology - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Neuropathy: motor
|
0.99%
5/505 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.79%
4/504 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Neuropathy: sensory
|
0.79%
4/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.4%
7/504 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Pain
|
5.0%
25/505 • Number of events 27
Participants who did not received allocated intervention were excluded from toxicity analysis
|
3.8%
19/504 • Number of events 24
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Seizure
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Somnolence/depressed level of consciousness
|
0.59%
3/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Syncope (fainting)
|
1.8%
9/505 • Number of events 10
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.4%
7/504 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Psychiatric disorders
Confusion
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Psychiatric disorders
Mood alteration
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Psychiatric disorders
Psychosis (hallucinations/delusions)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Bladder spasms
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Cystitis
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Fistula, GU
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Hemorrhage GU
|
1.2%
6/505 • Number of events 7
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.8%
9/504 • Number of events 10
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Obstruction, GU
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Perforation GU
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Proteinuria
|
4.4%
22/505 • Number of events 26
Participants who did not received allocated intervention were excluded from toxicity analysis
|
3.8%
19/504 • Number of events 21
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Renal failure
|
0.59%
3/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Stricture/stenosis (including anastomotic), GU
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.59%
3/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Adult Respiratory Distress Syndrome (ARDS)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm wheezing
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.59%
3/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
3.0%
15/505 • Number of events 18
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.4%
12/504 • Number of events 13
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary/upper respiratory
|
4.6%
23/505 • Number of events 23
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.99%
5/505 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
2.0%
10/505 • Number of events 12
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g. hoarseness loss or alteration in voice laryngitis)
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
1.4%
7/505 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.0%
10/504 • Number of events 15
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Skin breakdown/decubitus ulcer
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives welts wheals)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Hot flashes/flushes
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Hypertension
|
4.8%
24/505 • Number of events 27
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.2%
6/504 • Number of events 9
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Hypotension
|
2.2%
11/505 • Number of events 11
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.2%
6/504 • Number of events 7
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
3.4%
17/505 • Number of events 17
Participants who did not received allocated intervention were excluded from toxicity analysis
|
5.6%
28/504 • Number of events 31
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Vascular - Other
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
Other adverse events
| Measure |
Docetaxel + Placebo
n=505 participants at risk
Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
|
Docetaxel + Bevacizumab
n=504 participants at risk
Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
3.0%
15/505 • Number of events 15
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Blood and lymphatic system disorders
Hemoglobin
|
2.4%
12/505 • Number of events 20
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.8%
9/504 • Number of events 11
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Blood and lymphatic system disorders
Hemolysis (e.g. immune hemolytic anemia drug-related hemolysis)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Blood and lymphatic system disorders
Lymphatics - Other
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Cardiac Arrhythmia - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Cardiac General - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Cardiac ischemia/infarction
|
0.79%
4/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Edema
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
0.40%
2/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Ear and labyrinth disorders
Hearing: patients without baseline audiogram and not enrolled in a monitoring program
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Ear and labyrinth disorders
Otitis middle ear (non-infectious)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Eye disorders
Cataract
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Eye disorders
Vision-blurred vision
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Eye disorders
Watery eye (epiphora tearing)
|
2.0%
10/505 • Number of events 23
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 10
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Constipation
|
1.4%
7/505 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Dental: periodontal disease
|
0.20%
1/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Diarrhea
|
3.6%
18/505 • Number of events 19
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.4%
7/504 • Number of events 9
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
0.20%
1/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Dysphagia (difficulty swallowing)
|
0.20%
1/505 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Esophagitis
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Fistula, GI
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Gastrointestinal - Other
|
0.20%
1/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Hemorrhage, GI
|
6.5%
33/505 • Number of events 46
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.6%
13/504 • Number of events 19
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Ileus GI (functional obstruction of bowel i.e. neuroconstipation)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Incontinence anal
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Mucositis/stomatitis (clinical exam)
|
1.2%
6/505 • Number of events 7
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Mucositis/stomatitis (functional/symptomatic)
|
2.4%
12/505 • Number of events 20
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Nausea
|
1.6%
8/505 • Number of events 13
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.4%
7/504 • Number of events 7
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Perforation, GI
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Rectal bleeding/hematochezia
|
0.40%
2/505 • Number of events 11
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Ulcer, GI
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Gastrointestinal disorders
Vomiting
|
0.59%
3/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.79%
4/504 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Death not associated with CTCAE term
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Edema: limb
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Edema: trunk/genital
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Extremity-lower (gait/walking)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
17.8%
90/505 • Number of events 157
Participants who did not received allocated intervention were excluded from toxicity analysis
|
10.1%
51/504 • Number of events 80
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Fever
|
15.2%
77/505 • Number of events 105
Participants who did not received allocated intervention were excluded from toxicity analysis
|
9.9%
50/504 • Number of events 64
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Pain - Other
|
0.79%
4/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.2%
6/504 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Rigors/chills
|
8.3%
42/505 • Number of events 73
Participants who did not received allocated intervention were excluded from toxicity analysis
|
6.5%
33/504 • Number of events 67
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
General disorders
Syndromes - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
4.0%
20/505 • Number of events 56
Participants who did not received allocated intervention were excluded from toxicity analysis
|
5.2%
26/504 • Number of events 47
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Infection
|
5.7%
29/505 • Number of events 40
Participants who did not received allocated intervention were excluded from toxicity analysis
|
3.0%
15/504 • Number of events 18
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Infection - Other
|
2.4%
12/505 • Number of events 23
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.2%
6/504 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
7.1%
36/505 • Number of events 61
Participants who did not received allocated intervention were excluded from toxicity analysis
|
4.2%
21/504 • Number of events 28
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Infection with unknown ANC
|
5.0%
25/505 • Number of events 33
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.0%
10/504 • Number of events 14
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Infections and infestations
Infection without neutropenia
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Injury, poisoning and procedural complications
Vessel injury-artery
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
ALT, SGPT (serum glutamic pyruvic transaminase)
|
0.59%
3/505 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
AST, SGOT(serum glutamic oxaloacetic transaminase)
|
0.40%
2/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Alkaline phosphatase
|
2.4%
12/505 • Number of events 18
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.4%
12/504 • Number of events 29
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
CD4 count
|
0.20%
1/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Cholesterol serum-high (hypercholesteremia)
|
0.20%
1/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Creatinine
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
GGT (gamma-Glutamyl transpeptidase)
|
0.40%
2/505 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
INR (International Normalized Ratio of prothrombin time)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Leukocytes (total WBC)
|
11.1%
56/505 • Number of events 176
Participants who did not received allocated intervention were excluded from toxicity analysis
|
9.9%
50/504 • Number of events 113
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Lymphopenia
|
3.6%
18/505 • Number of events 87
Participants who did not received allocated intervention were excluded from toxicity analysis
|
6.2%
31/504 • Number of events 90
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Metabolic/Laboratory - Other
|
0.79%
4/505 • Number of events 12
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Neutrophils/granulocytes (ANC/AGC)
|
21.8%
110/505 • Number of events 312
Participants who did not received allocated intervention were excluded from toxicity analysis
|
19.2%
97/504 • Number of events 252
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
PTT (Partial Thromboplastin Time)
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Platelets
|
0.40%
2/505 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Weight gain
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 19
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Investigations
Weight loss
|
0.99%
5/505 • Number of events 10
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
0.79%
4/505 • Number of events 15
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Anorexia
|
2.8%
14/505 • Number of events 24
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 7
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Calcium serum-low (hypocalcemia)
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
6/505 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.79%
4/504 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Glucose serum-high (hyperglycemia)
|
9.5%
48/505 • Number of events 142
Participants who did not received allocated intervention were excluded from toxicity analysis
|
7.9%
40/504 • Number of events 82
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Magnesium serum-low (hypomagnesemia)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Pancreatic endocrine: glucose intolerance
|
0.20%
1/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Phosphate serum-low (hypophosphatemia)
|
0.59%
3/505 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Potassium serum-high (hyperkalemia)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Potassium serum-low (hypokalemia)
|
0.59%
3/505 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Metabolism and nutrition disorders
Sodium serum-low (hyponatremia)
|
1.8%
9/505 • Number of events 13
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Musculoskeletal and connective tissue disorders
Arthritis (non-septic)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness, generalized or specific area (not due to neuropathy)
|
1.4%
7/505 • Number of events 13
Participants who did not received allocated intervention were excluded from toxicity analysis
|
2.0%
10/504 • Number of events 11
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue - Other
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis (avascular necrosis)
|
0.79%
4/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - possibly related to cancer treatment
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Ataxia (incoordination)
|
0.40%
2/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Cognitive disturbance
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Dizziness
|
0.59%
3/505 • Number of events 5
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Encephalopathy
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Hemorrhage CNS
|
0.20%
1/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Neurology - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Neuropathy: cranial
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Neuropathy: motor
|
1.8%
9/505 • Number of events 14
Participants who did not received allocated intervention were excluded from toxicity analysis
|
3.4%
17/504 • Number of events 32
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Neuropathy: sensory
|
6.5%
33/505 • Number of events 50
Participants who did not received allocated intervention were excluded from toxicity analysis
|
6.5%
33/504 • Number of events 67
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Pain
|
8.7%
44/505 • Number of events 64
Participants who did not received allocated intervention were excluded from toxicity analysis
|
6.7%
34/504 • Number of events 43
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Pyramidal tract dysfunction
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Syncope (fainting)
|
0.99%
5/505 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 7
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Taste alteration (dysgeusia)
|
0.59%
3/505 • Number of events 10
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Nervous system disorders
Vasovagal episode
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Psychiatric disorders
Insomnia
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Psychiatric disorders
Mood alteration
|
0.59%
3/505 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Psychiatric disorders
Personality/behavioral
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Bladder spasms
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Cystitis
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Fistula, GU
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Hematuria (in the absence of vaginal bleeding)
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Hemoglobinuria
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Hemorrhage GU
|
0.40%
2/505 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.2%
6/504 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Incontinence, urinary
|
0.59%
3/505 • Number of events 13
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.60%
3/504 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Obstruction, GU
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Proteinuria
|
17.6%
89/505 • Number of events 295
Participants who did not received allocated intervention were excluded from toxicity analysis
|
13.9%
70/504 • Number of events 174
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Renal/Genitourinary - Other
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Stricture/stenosis (including anastomotic), GU
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.79%
4/504 • Number of events 4
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
0.99%
5/505 • Number of events 12
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.79%
4/504 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis (including sneezing nasal stuffiness postnasal drip)
|
0.20%
1/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.59%
3/505 • Number of events 7
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
1.6%
8/505 • Number of events 12
Participants who did not received allocated intervention were excluded from toxicity analysis
|
1.4%
7/504 • Number of events 7
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage pulmonary/upper respiratory
|
30.3%
153/505 • Number of events 603
Participants who did not received allocated intervention were excluded from toxicity analysis
|
10.7%
54/504 • Number of events 123
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Nasal cavity/paranasal sinus reactions
|
0.40%
2/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
0.59%
3/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes/dysarthria (e.g. hoarseness loss or alteration in voice laryngitis)
|
1.2%
6/505 • Number of events 11
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Hair loss/alopecia (scalp or body)
|
1.4%
7/505 • Number of events 17
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 12
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Nail changes
|
1.6%
8/505 • Number of events 17
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.99%
5/504 • Number of events 7
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
13.7%
69/505 • Number of events 155
Participants who did not received allocated intervention were excluded from toxicity analysis
|
11.1%
56/504 • Number of events 119
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Rash: hand-foot skin reaction
|
0.40%
2/505 • Number of events 11
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Sweating (diaphoresis)
|
0.40%
2/505 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Ulceration
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Skin and subcutaneous tissue disorders
Urticaria (hives welts wheals)
|
2.0%
10/505 • Number of events 15
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.79%
4/504 • Number of events 8
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Dermal change lymphedema phlebolymphedema
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Flushing
|
0.20%
1/505 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Hemorrhage/Bleeding - Other
|
0.00%
0/505
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.40%
2/504 • Number of events 2
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Hot flashes/flushes
|
0.79%
4/505 • Number of events 6
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.00%
0/504
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Hypertension
|
30.9%
156/505 • Number of events 568
Participants who did not received allocated intervention were excluded from toxicity analysis
|
16.3%
82/504 • Number of events 198
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Hypotension
|
0.59%
3/505 • Number of events 3
Participants who did not received allocated intervention were excluded from toxicity analysis
|
0.20%
1/504 • Number of events 1
Participants who did not received allocated intervention were excluded from toxicity analysis
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
1.4%
7/505 • Number of events 12
Participants who did not received allocated intervention were excluded from toxicity analysis
|
4.0%
20/504 • Number of events 61
Participants who did not received allocated intervention were excluded from toxicity analysis
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60