TriangleNCT02799602 · OUTCOME
OS From Date of Randomization Until Death From Any Cause - 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 until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)
What was measured
Overall survival (OS) was defined as the time from the date of randomization until death from any cause. 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. Long-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study.
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 | 229 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Docetaxel | 304 | Not reported | Not reported | Not reported | Not reported |
Number of patients censored
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Darolutamide (BAY1841788) + Docetaxel | 422 | Not reported | Not reported | Not reported | Not reported |
| Placebo + Docetaxel | 350 | Not reported | Not reported | Not reported | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.568
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.801
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).
- p Value
- <0.0001
- p Value Comment
- One-sided p-value.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.675
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.568
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.801
- group Ids
- OG000
- OG001
- non Inferiority Comment
- Hazard ratio \< 1 indicates superiority of Darolutamide+docetaxel arm over Placebo+docetaxel arm. Hazard ratio and 95% CI was based on Cox Regression Model, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).
- non Inferiority Type
- SUPERIORITY
- other Analysis Description
- One-sided p-value from log-rank test, stratified by EOD (Non-regional lymph nodes metastases only vs. Bone metastases with or without lymph node metastases vs. Visceral metastases with or without lymph node metastases or with or without bone metastases) and ALP (\<ULN vs. \>=ULN).
- p Value
- <0.0001
- p Value Comment
- One-sided p-value.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.675
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- value
- 229
- group Id
- OG001
- value
- 304
- title
- Number of patients with event
- categories
- measurements
- group Id
- OG000
- value
- 422
- group Id
- OG001
- value
- 350
- title
- Number of patients censored
- denoms
- counts
- group Id
- OG000
- value
- 651
- group Id
- OG001
- value
- 654
- units
- Participants
- description
- Overall survival (OS) was defined as the time from the date of randomization until death from any cause. 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. Long-term (Survival) follow-up period: After Active follow-up, patients continued to be contacted approximately every 12 weeks by phone. The end of the Survival follow-up period was defined as when the patient died, was lost to follow-up, withdrew consent, or at the end-of-study.
- 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 until death from any cause up to 25 OCT 2021 cut-off date 533 OS events were reached (approximate 59 months)
- title
- OS From Date of Randomization Until Death From Any Cause - Number of Events
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice