TriangleNCT02799602 · OUTCOME
Time to Worsening of Disease-Related Physical Symptoms - Number of Events
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 randomization of the first participant to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to 25 OCT 2021 cut-off date approximately 59 months
What was measured
Time to worsening of disease-related physical symptoms was defined as the time from randomization to the first date a patient experienced an increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
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 | Source count |
|---|---|
| Darolutamide (BAY1841788) + Docetaxel | 651 |
| Placebo + Docetaxel | 654 |
Reported measurements
Number (%) of patients with event
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Darolutamide (BAY1841788) + Docetaxel | 351 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Docetaxel | 308 | Not reported | Not reported | Not reported | Not reported |
Number (%) of patients censored
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Darolutamide (BAY1841788) + Docetaxel | 300 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Docetaxel | 346 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 351
- group Id
- OG001
- value
- 308
- title
- Number (%) of patients with event
- categories
- measurements
- group Id
- OG000
- value
- 300
- group Id
- OG001
- value
- 346
- title
- Number (%) of patients censored
- denoms
- counts
- group Id
- OG000
- value
- 651
- group Id
- OG001
- value
- 654
- units
- Participants
- description
- Time to worsening of disease-related physical symptoms was defined as the time from randomization to the first date a patient experienced an increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire. Treatment period: treatment was provided for all patients, twice daily, until disease progression (symptomatic progressive disease, change of systemic antineoplastic therapy), unacceptable toxicity, consent withdrawal, withdrawal at the discretion of the investigator, death, or non-compliance. Active follow-up visits from the discontinuation of the darolutamide or placebo treatment period for up to 1 year or until the patient could no longer travel to the clinic, died, was lost to follow-up, or withdrew informed consent and actively objected to collection of further data.
- 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
- reporting Status
- POSTED
- time Frame
- From randomization of the first participant to the first increase in disease-related physical symptoms based on the NCCN-FACT-FPSI-17 questionnaire up to 25 OCT 2021 cut-off date approximately 59 months
- title
- Time to Worsening of Disease-Related Physical Symptoms - Number of Events
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice