TriangleNCT01546038 · OUTCOME
Overall Survival (OS) at Phase 2 Unfit
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Months
- Interval / dispersion
- 80% Confidence Interval
- Time frame
- Randomization to Follow-up (4 years)
What was measured
OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from time of randomization for each participant.
Analysis population: Full analysis set: all randomized participants of Phase 2 Unfit arm.
Groups in this outcome
Phase 2 Unfit: Glasdegib 100 mg + LDAC
Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
Phase 2 Unfit: LDAC Alone
Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
| Group | Source count |
|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 88 |
| Phase 2 Unfit: LDAC Alone | 44 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Phase 2 Unfit: Glasdegib 100 mg + LDAC | 8.8 | Not reported | 6.9 | 9.9 | Not reported |
| Phase 2 Unfit: LDAC Alone | 4.9 | Not reported | 3.5 | 6.0 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.441
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 80
- ci Upper Limit
- 0.734
- estimate Comment
- Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0020
- p Value Comment
- 1-sided p-value from the log-rank test stratified by prognosis stratum according to Interactive Voice Response System (IVRS).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.569
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.441
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 80
- ci Upper Limit
- 0.734
- estimate Comment
- Based on the Cox proportional hazards model stratified by prognosis stratum according to IVRS.
- group Ids
- OG000
- OG001
- non Inferiority Type
- OTHER
- p Value
- 0.0020
- p Value Comment
- 1-sided p-value from the log-rank test stratified by prognosis stratum according to Interactive Voice Response System (IVRS).
- param Type
- Hazard Ratio (HR)
- param Value
- 0.569
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 6.9
- upper Limit
- 9.9
- value
- 8.8
- group Id
- OG001
- lower Limit
- 3.5
- upper Limit
- 6.0
- value
- 4.9
- denoms
- counts
- group Id
- OG000
- value
- 88
- group Id
- OG001
- value
- 44
- units
- Participants
- description
- OS was defined as duration from the date of randomization to the date of death from any cause. Kaplan-Meier (KM) method was used to estimate median OS. In this method, every participant had a follow-up time which was associated with an indicator, 1=event (death in our case), and 0 =censored. If the participants were not known to have died, time to date of last known to be alive was used as to calculate the follow-up time and indicator was 0 for these participants. KM method estimates the median OS based on the K-M curve. The K-M curve only drops when we had an event and censor data are the ticks in the graph. To estimate median OS, the K-M curve usually will be smoothed first and a line will be drawn at 50%. The median OS is the point when K-M curve and the horizontal hit. Survival status was collected every month for the first 2 months after discontinuation of study treatment and thereafter every 2 months until death or 4 years from time of randomization for each participant.
- dispersion Type
- 80% Confidence Interval
- groups
- description
- Participants received oral doses of glasdegib tablets 100 mg QD in 28-day cycles on a continuous basis, starting on Day 1 of Cycle 1. LDAC was given at a dose of 20 mg subcutaneously BID on Days 1-10 of the 28 day cycles.
- id
- OG000
- title
- Phase 2 Unfit: Glasdegib 100 mg + LDAC
- description
- Participants received LDAC subcutaneously at a dose of 20 mg BID on Days 1-10 of the 28 day cycles.
- id
- OG001
- title
- Phase 2 Unfit: LDAC Alone
- param Type
- MEDIAN
- population Description
- Full analysis set: all randomized participants of Phase 2 Unfit arm.
- reporting Status
- POSTED
- time Frame
- Randomization to Follow-up (4 years)
- title
- Overall Survival (OS) at Phase 2 Unfit
- type
- PRIMARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice