Trial Outcomes & Findings for Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer (NCT NCT00116142)
NCT ID: NCT00116142
Last Updated: 2022-01-11
Results Overview
Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
350 participants
Primary outcome timeframe
Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.
Results posted on
2022-01-11
Participant Flow
9/21/2005 to 1/13/2015
Participant milestones
| Measure |
Arm1: Androgen Suppression Therapy + Radiation Therapy
Androgen Suppression Therapy + Radiation therapy
Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression
|
Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression
|
|---|---|---|
|
Overall Study
STARTED
|
175
|
175
|
|
Overall Study
Treated
|
174
|
171
|
|
Overall Study
COMPLETED
|
156
|
155
|
|
Overall Study
NOT COMPLETED
|
19
|
20
|
Reasons for withdrawal
| Measure |
Arm1: Androgen Suppression Therapy + Radiation Therapy
Androgen Suppression Therapy + Radiation therapy
Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression
|
Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression
|
|---|---|---|
|
Overall Study
Adverse Event
|
8
|
7
|
|
Overall Study
Protocol Violation
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
5
|
5
|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Delayed Radiation Therapy
|
1
|
0
|
|
Overall Study
Patient could not tolerate docetaxel
|
0
|
2
|
|
Overall Study
Patient stopped due to depression
|
0
|
1
|
|
Overall Study
Patient stopped due to bilateral ruptured tendons
|
0
|
1
|
|
Overall Study
Patient didn't start due to diagnosis of colon cancer
|
0
|
1
|
|
Overall Study
Patient didn't start due to low platelet counts
|
0
|
1
|
Baseline Characteristics
Hormone Suppression and Radiation Therapy for 6 Months With/Without Docetaxel for High Risk Prostate Cancer
Baseline characteristics by cohort
| Measure |
Arm1: Androgen Suppression Therapy + Radiation Therapy
n=175 Participants
Androgen Suppression Therapy + Radiation therapy
Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression
|
Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
n=175 Participants
Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles Weeks 18-26: total androgen suppression
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=99 Participants
|
66 years
n=107 Participants
|
66 years
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
|
175 Participants
n=99 Participants
|
175 Participants
n=107 Participants
|
350 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
139 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
271 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
29 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
110 Participants
n=99 Participants
|
102 Participants
n=107 Participants
|
212 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
62 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
131 Participants
n=206 Participants
|
|
Region of Enrollment
New Zealand
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.Overall survival (OS) was measured from the date of random assignment to death from any cause, censored at the date of last follow-up in surviving patients. The 10-Year Restricted Mean Survival Time was calculated as the area under the Kaplan Meier plot for OS, from randomization to 10-years follow-up
Outcome measures
| Measure |
Arm1: Androgen Suppression Therapy + Radiation Therapy
n=175 Participants
Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression
|
Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
n=175 Participants
Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles
Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles
Weeks 18-26: total androgen suppression
|
|---|---|---|
|
10-Year Restricted Mean Survival Time for Overall Survival
|
8.82 years
Standard Error 0.19
|
9.11 years
Standard Error 0.15
|
SECONDARY outcome
Timeframe: PSA was measured following the end of RT, then every 6 months for 5 years and annually thereafter, 10 yearsTime to biochemical recurrence was defined as the time from date of random assignment to the earliest of PSA failure or initiation of salvage therapy, or censored at the date of last disease assessment for those without PSA failure. PSA failure was defined according to the 2006 RTOG-ASTRO Phoenix definition (i.e., A PSA rise by 2 ng/mL or more above the nadir). 10-year biochemical recurrence rate was estimated from a competing risk model where non-prostate cancer death was counted as competing risk.
Outcome measures
| Measure |
Arm1: Androgen Suppression Therapy + Radiation Therapy
n=175 Participants
Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression
|
Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
n=175 Participants
Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles
Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles
Weeks 18-26: total androgen suppression
|
|---|---|---|
|
10-year Biochemical Recurrence (PSA Failure)
|
48 percentage of subjects
Interval 39.0 to 55.0
|
54 percentage of subjects
Interval 46.0 to 62.0
|
SECONDARY outcome
Timeframe: Following the end of RT patients were seen for follow up every 6 months for 5 years and annually thereafter, 10 years.Measured from the date of random assignment to date of death from prostate cancer, or censored at the date of last follow-up in surviving patients. Patients who died due to other reasons were counted as competing risk in a competing risk model.
Outcome measures
| Measure |
Arm1: Androgen Suppression Therapy + Radiation Therapy
n=175 Participants
Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression
|
Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
n=175 Participants
Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles
Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles
Weeks 18-26: total androgen suppression
|
|---|---|---|
|
10-year Prostate Cancer Mortality
|
11 percentage of subjects
Interval 7.0 to 17.0
|
15 percentage of subjects
Interval 10.0 to 22.0
|
SECONDARY outcome
Timeframe: During study treatment or within 30 days of the last dose of study, up to 7.2 months from randomizationPopulation: Adverse acute events were evaluated in patients who received at least one dose of protocol treatment (174 out of 175 subjects in Arm1, 171 out of 175 subjects in Arm2).
Adverse acute events were reported via the clinical database only for toxicities considered reportable via the SAE mechanism (those of grade 2 and grade 3 events that are unexpected and possibly, probably, or definitely related/associated with treatment; or all grade 4 and grade 5 events). Common Toxicity Criteria Volume 3.0 (CTCAE) is used for this study.
Outcome measures
| Measure |
Arm1: Androgen Suppression Therapy + Radiation Therapy
n=174 Participants
Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression
|
Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
n=171 Participants
Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles
Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles
Weeks 18-26: total androgen suppression
|
|---|---|---|
|
Number of Participants With Acute Adverse Events
|
18 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Every 6 months post radiation therapy for 5 years (+/-90 days), then annually, up to 13.9 years from randomizationPopulation: Adverse late event was evaluated in patients who received at least one dose of protocol treatment (174 out of 175 subjects in Arm1, 171 out of 175 subjects in Arm2).
Late adverse events will be focused on GU/GI including Urinary/Fecal Incontinence, Hematuria, Diarrhea, Rectal Bleeding and other.
Outcome measures
| Measure |
Arm1: Androgen Suppression Therapy + Radiation Therapy
n=174 Participants
Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression Weeks 10-17: total androgen suppression and external beam radiation Weeks 18-26: total androgen suppression
|
Arm2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
n=171 Participants
Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Weeks 1-9: total androgen suppression and docetaxel 60 mg/m2/q3 weeks x 3 cycles
Weeks 10-17: total androgen suppression + external beam radiation therapy + docetaxel 20 mg/m2/week beginning at week 10 x 7 cycles
Weeks 18-26: total androgen suppression
|
|---|---|---|
|
Number of Participants With Late Adverse Events, Any Grade and Attribution
|
128 Participants
|
140 Participants
|
Adverse Events
Arm1: Androgen Suppression Therapy + Radiation Therapy
Serious events: 63 serious events
Other events: 128 other events
Deaths: 45 deaths
Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
Serious events: 87 serious events
Other events: 142 other events
Deaths: 44 deaths
Serious adverse events
| Measure |
Arm1: Androgen Suppression Therapy + Radiation Therapy
n=174 participants at risk
Androgen Suppression Therapy and Radiation therapy
Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy
Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy
|
Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
n=171 participants at risk
Docetaxel plus androgen suppression therapy and radiation therapy
Docetaxel: 60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.
Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy
Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy
|
|---|---|---|
|
Investigations
Weight loss
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Perforation, colon
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Skin and subcutaneous tissue disorders
Skin-other
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Ulcer, duodenum
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Cardiac disorders
Cardiac-ischemia
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Cystitis
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Vascular disorders
Hot flashes
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Constipation
|
1.1%
2/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Injury, poisoning and procedural complications
Bladder anastomotic leak
|
1.1%
2/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Respiratory, thoracic and mediastinal disorders
(ARDS)
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm, wheezing
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Injury, poisoning and procedural complications
C5 tetraplegia
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Nervous system disorders
CNS cerebrovascular ischemia
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
General disorders
Fever w/o neutropenia
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Reproductive system and breast disorders
Gynecomastia
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Infections and infestations
Infection w/ gr 3-4 neut, blood
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Infections and infestations
Infection w/ unk ANC lung
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Investigations
Leukocytes
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Hepatobiliary disorders
Liver dysfunction/failure
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/soft tissue-other
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Immune system disorders
Allergic reaction
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.2%
2/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.2%
2/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.2%
2/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Infections and infestations
Infection-other
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.2%
2/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Proctitis
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.8%
3/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
4/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.8%
3/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Cardiac disorders
Cardiac-other
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
2.3%
4/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
2.3%
4/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Reproductive system and breast disorders
Erectile impotence
|
1.7%
3/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
3.5%
6/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Incontinence, anal
|
4.0%
7/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
3.5%
6/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
5.2%
9/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
4.1%
7/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Incontinence urinary
|
6.3%
11/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
4.7%
8/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Investigations
Neutrophils
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
4.7%
8/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
GI-other
|
5.7%
10/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
5.3%
9/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Bladder, hemorrhage
|
5.7%
10/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
5.2%
9/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
9.9%
17/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
5.7%
10/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
10.5%
18/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Renal/GU-other
|
9.8%
17/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
15.8%
27/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Bladder spasms
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
General disorders
Constitutional, other
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
General disorders
Death - sudden death
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Distention/bloating, abdominal
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Endocrine disorders
Endocrine-other
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Enteritis
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Infections and infestations
Infection Gr0-2 neut, lung
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Psychiatric disorders
Depression
|
1.1%
2/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
General disorders
Fatigue
|
1.1%
2/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
2/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
Other adverse events
| Measure |
Arm1: Androgen Suppression Therapy + Radiation Therapy
n=174 participants at risk
Androgen Suppression Therapy and Radiation therapy
Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy
Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy
|
Arm 2: Docetaxel + Androgen Suppression Therapy + Radiation Therapy
n=171 participants at risk
Docetaxel plus androgen suppression therapy and radiation therapy
Docetaxel: 60 mg/m² q 3 weeks for 3 cycle at the start of treatment followed by weekly Docetaxel at 20 mg/m² per week beginning at week one of radiation therapy and continuing for seven weeks.
Androgen Hormonal Suppression and Radiation: Total Androgen Ablation and external beam radiation therapy
Androgen Suppression Therapy and Radiation Therapy: Total Androgen Ablation and External Beam Radiation Therapy
|
|---|---|---|
|
Investigations
ALT, SGPT
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Bladder spasms
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Bladder, hemorrhage
|
13.2%
23/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
18.1%
31/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Cardiac disorders
Cardiac-other
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
General disorders
Chest/thoracic pain NOS
|
1.1%
2/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Constipation
|
13.8%
24/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
9.9%
17/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
General disorders
Constitutional, other
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Cystitis
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Psychiatric disorders
Depression
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Diarrhea w/o prior colostomy
|
24.1%
42/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
29.2%
50/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.2%
2/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Reproductive system and breast disorders
Erectile impotence
|
2.9%
5/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
2.3%
4/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
GI-other
|
17.8%
31/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
19.9%
34/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Vascular disorders
Hypertension
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Vascular disorders
Hypotension
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.2%
2/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Incontinence urinary
|
20.1%
35/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
30.4%
52/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Incontinence, anal
|
12.1%
21/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
18.7%
32/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Infections and infestations
Infection Gr0-2 neut, urinary tract
|
1.1%
2/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.2%
2/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Infections and infestations
Infection w/ unk ANC wound
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Infections and infestations
Infection-other
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Injury, poisoning and procedural complications
Bladder anastomotic leak
|
10.9%
19/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
14.6%
25/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.2%
2/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.57%
1/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.00%
0/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.2%
2/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory-other
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Rectum, hemorrhage
|
28.2%
49/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
24.0%
41/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Renal/GU-other
|
40.2%
70/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
49.1%
84/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
General disorders
Rigors/chills
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Stenosis (incl anastomotic) small bowel
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Reproductive system and breast disorders
Testicle, pain
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Gastrointestinal disorders
Upper GI, hemorrhage NOS
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
0.58%
1/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
28.2%
49/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
29.2%
50/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Renal and urinary disorders
Urinary retention
|
1.1%
2/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
3.5%
6/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
|
Nervous system disorders
Vasovagal episode
|
0.00%
0/174 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
1.2%
2/171 • Up to 13.9 years from randomization.
Adverse acute events were reported via trial database only for those deemed reportable via the SAE mechanism (grade 2/3 events that are unexpected and possibly, probably, or definitely related to treatment; or all grade 4/5 events). Adverse late events include GU/GI toxicities. Adverse event was analyzed in patients who received at least one dose of study therapy (Arm1:174 out of 175 subjects, Arm2:171 out of 175). Mortality was analyzed in all randomized subjects by the intent-to-treat rule.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place