TriangleNCT02125461 · OUTCOME
Percentage of Patients Alive at 24 Months (OS24)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of patients
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
What was measured
OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months.
Analysis population: FAS included all randomized patients, analyzed on an ITT basis.
Groups in this outcome
Durvalumab (MEDI4736)
Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
Placebo
Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
| Group | Source count |
|---|---|
| Durvalumab (MEDI4736) | 476 |
| Placebo | 237 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Durvalumab (MEDI4736) | 66.3 | Not reported | 61.7 | 70.4 | Not reported |
| Placebo | 55.6 | Not reported | 48.9 | 61.8 | Not reported |
Source statistical analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.005
- p Value Comment
- P-value generated based on z-test where z-test statistic is the ratio of the log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by the square root of the variance.
- statistical Comment
- The variance was estimated using the delta method and Greenwood's formula.
- statistical Method
- z-test
Complete source fields
- analyses
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- 0.005
- p Value Comment
- P-value generated based on z-test where z-test statistic is the ratio of the log-transformed ratio of the cumulative hazards in the 2 treatment arms divided by the square root of the variance.
- statistical Comment
- The variance was estimated using the delta method and Greenwood's formula.
- statistical Method
- z-test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 61.7
- upper Limit
- 70.4
- value
- 66.3
- group Id
- OG001
- lower Limit
- 48.9
- upper Limit
- 61.8
- value
- 55.6
- denoms
- counts
- group Id
- OG000
- value
- 476
- group Id
- OG001
- value
- 237
- units
- Participants
- description
- OS24 was defined as the percentage of patients who were alive at 24 months after randomization per the Kaplan-Meier estimate of OS at 24 months.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients in the durvalumab (MEDI4736) monotherapy group were to receive durvalumab 10 mg/kg Q2W via intravenous infusion for up to 12 months.
- id
- OG000
- title
- Durvalumab (MEDI4736)
- description
- Patients in the placebo group were to receive matching placebo for intravenous infusion Q2W for up to 12 months.
- id
- OG001
- title
- Placebo
- param Type
- NUMBER
- population Description
- FAS included all randomized patients, analyzed on an ITT basis.
- reporting Status
- POSTED
- time Frame
- From baseline until death due to any cause. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
- title
- Percentage of Patients Alive at 24 Months (OS24)
- type
- SECONDARY
- unit Of Measure
- Percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice