TriangleNCT05386550 · OUTCOME
Disease-Free Survival (DFS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- Full Range
- Time frame
- Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 22.7 months
What was measured
DFS defined as the time from randomization to the first occurrence of any of the following events: Death from any cause; Objective Disease Recurrence (earlier date of first imaging or biopsy collection confirming event at a DFS assessment): Local or regional relapse which is subsequently confirmed by histopathology unless medically contraindicated or medical risk of biopsy deemed too high: Distant metastases. Confirmation of pathology is recommended in case of solitary metastasis (especially in the lung) after considering potential contraindication and/or medical risk associated with biopsy. DFS time was estimated according to Kaplan-Meier method.
Analysis population: Full Analysis Set (FAS) included all participants who were randomized to study treatment.
Groups in this outcome
Xevinapant +IMRT
Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
Placebo +IMRT
Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle in combination with with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
| Group | Source count |
|---|---|
| Xevinapant +IMRT | 81 |
| Placebo +IMRT | 85 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Xevinapant +IMRT | 11.10 | Not reported | 0.03 | 19.32 | Not reported |
| Placebo +IMRT | 7.29 | Not reported | 0.03 | 14.65 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.03
- upper Limit
- 19.32
- value
- 11.10
- group Id
- OG001
- lower Limit
- 0.03
- upper Limit
- 14.65
- value
- 7.29
- denoms
- counts
- group Id
- OG000
- value
- 81
- group Id
- OG001
- value
- 85
- units
- Participants
- description
- DFS defined as the time from randomization to the first occurrence of any of the following events: Death from any cause; Objective Disease Recurrence (earlier date of first imaging or biopsy collection confirming event at a DFS assessment): Local or regional relapse which is subsequently confirmed by histopathology unless medically contraindicated or medical risk of biopsy deemed too high: Distant metastases. Confirmation of pathology is recommended in case of solitary metastasis (especially in the lung) after considering potential contraindication and/or medical risk associated with biopsy. DFS time was estimated according to Kaplan-Meier method.
- dispersion Type
- Full Range
- groups
- description
- Participants received 3 cycles of oral solution of Xevinapant at a dose of 200 milligrams per day (mg/day) once daily from Day 1 to 14, per 3-week cycle in combination with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of Xevinapant at a dose of 200 mg/day from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
- id
- OG000
- title
- Xevinapant +IMRT
- description
- Participants received 3 cycles of oral solution of placebo matched to Xevinapant once daily from Day 1 to 14 per 3-week cycle in combination with with 66 Gray (Gy) of intensity modulated radiation therapy (IMRT) in 33 fractions, 2 Gy/fraction, 5 days/week followed by 3 cycles of monotherapy of placebo matched to Xevinapant from Day 1 to 14, per 3-week cycle (Each cycle is of 3 weeks).
- id
- OG001
- title
- Placebo +IMRT
- param Type
- MEDIAN
- population Description
- Full Analysis Set (FAS) included all participants who were randomized to study treatment.
- reporting Status
- POSTED
- time Frame
- Time from randomization to the first occurrence of death from any cause or objective disease recurrence, assessed up to 22.7 months
- title
- Disease-Free Survival (DFS)
- type
- PRIMARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice