NCT02799602 · OUTCOME
Number of Participants With TEAEs
Darolutamide in Addition to Standard Androgen Deprivation Therapy and Docetaxel in Metastatic Hormone-Sensitive Prostate Cancer · Source last updated 2025-12-04
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From the first dose of darolutamide or placebo until 30 days after the last dose of darolutamide or placebo administration up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)
What was measured
TEAEs = Treatment-emergent adverse events, were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.
Analysis population: The number of patients who started treatment is presented based on the randomized treatment assignment. One patient was randomized to the placebo+docetaxel arm but received at least one dose of darolutamide. This patient was included in the darolutamide+docetaxel arm in the analysis of all safety variables.
Groups in this outcome
Darolutamide (BAY1841788) + Docetaxel
Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).
Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.
ADT administration started ≤12 weeks before randomization.
Placebo + Docetaxel
Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.
ADT administration started ≤12 weeks before randomization.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 652 |
|---|
| Placebo + Docetaxel | 650 |
|---|
Reported measurements
Any TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 649 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 643 | Not reported | Not reported | Not reported | Not reported |
|---|
TESAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 306 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 276 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE leading to study drug dose modification
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 172 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 112 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE leading to permanent discontinuation of study drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 90 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 69 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE leading to docetaxel dose modification
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 216 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 214 | Not reported | Not reported | Not reported | Not reported |
|---|
TEAE leading to permanent discontinuation of docetaxel
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 52 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 67 | Not reported | Not reported | Not reported | Not reported |
|---|
Related to protocol-required procedure
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 69 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 64 | Not reported | Not reported | Not reported | Not reported |
|---|
Any study drug-related TEAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 344 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 309 | Not reported | Not reported | Not reported | Not reported |
|---|
Study drug-related TESAE
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 30 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
Study drug-related TEAE leading to study drug dose modification
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 75 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 41 | Not reported | Not reported | Not reported | Not reported |
|---|
Study drug-related TEAE leading to permanent discontinuation of study drug
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Darolutamide (BAY1841788) + Docetaxel | 25 | Not reported | Not reported | Not reported | Not reported |
|---|
| Placebo + Docetaxel | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 649
- group Id
- OG001
- value
- 643
- title
- Any TEAE
- categories
- measurements
- group Id
- OG000
- value
- 306
- group Id
- OG001
- value
- 276
- title
- TESAE
- categories
- measurements
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 112
- title
- TEAE leading to study drug dose modification
- categories
- measurements
- group Id
- OG000
- value
- 90
- group Id
- OG001
- value
- 69
- title
- TEAE leading to permanent discontinuation of study drug
- categories
- measurements
- group Id
- OG000
- value
- 216
- group Id
- OG001
- value
- 214
- title
- TEAE leading to docetaxel dose modification
- categories
- measurements
- group Id
- OG000
- value
- 52
- group Id
- OG001
- value
- 67
- title
- TEAE leading to permanent discontinuation of docetaxel
- categories
- measurements
- group Id
- OG000
- value
- 69
- group Id
- OG001
- value
- 64
- title
- Related to protocol-required procedure
- categories
- measurements
- group Id
- OG000
- value
- 344
- group Id
- OG001
- value
- 309
- title
- Any study drug-related TEAE
- categories
- measurements
- group Id
- OG000
- value
- 30
- group Id
- OG001
- value
- 24
- title
- Study drug-related TESAE
- categories
- measurements
- group Id
- OG000
- value
- 75
- group Id
- OG001
- value
- 41
- title
- Study drug-related TEAE leading to study drug dose modification
- categories
- measurements
- group Id
- OG000
- value
- 25
- group Id
- OG001
- value
- 13
- title
- Study drug-related TEAE leading to permanent discontinuation of study drug
- denoms
- counts
- group Id
- OG000
- value
- 652
- group Id
- OG001
- value
- 650
- units
- Participants
- description
- TEAEs = Treatment-emergent adverse events, were defined as any event(s) arising or worsening after the first dose of darolutamide or placebo, until 30 days after the last dose of darolutamide or placebo administration.
- groups
- description
- Participants received darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT).
Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.
ADT administration started ≤12 weeks before randomization.
- id
- OG000
- title
- Darolutamide (BAY1841788) + Docetaxel
- description
- Participants received matching placebo to darolutamide in addition to their standard treatment with docetaxel and androgen deprivation therapy (ADT). Docetaxel was administered for six cycles after randomization. The first cycle of docetaxel was administered within 6 weeks after start of study drug.
ADT administration started ≤12 weeks before randomization.
- id
- OG001
- title
- Placebo + Docetaxel
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- The number of patients who started treatment is presented based on the randomized treatment assignment. One patient was randomized to the placebo+docetaxel arm but received at least one dose of darolutamide. This patient was included in the darolutamide+docetaxel arm in the analysis of all safety variables.
- reporting Status
- POSTED
- time Frame
- From the first dose of darolutamide or placebo until 30 days after the last dose of darolutamide or placebo administration up to cut-off date for the final completion analysis 11 APR 2023 (approximately 77 months)
- title
- Number of Participants With TEAEs
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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