TriangleNCT02125461 · OUTCOME
Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1
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
- Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
What was measured
ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
Analysis population: FAS (which included all randomized patients) with measureable disease at baseline, 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) | 443 |
| Placebo | 213 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Durvalumab (MEDI4736) | 30.0 | Not reported | 25.79 | 34.53 | Not reported |
| Placebo | 17.8 | Not reported | 12.95 | 23.65 | Not reported |
Source statistical analyses
- group Description
- Analysis performed using Fisher's exact test with mid p-value modification by subtracting half of the probability of the observed table from Fisher's p-value.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Method
- Fisher Exact
Complete source fields
- analyses
- group Description
- Analysis performed using Fisher's exact test with mid p-value modification by subtracting half of the probability of the observed table from Fisher's p-value.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Method
- Fisher Exact
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 25.79
- upper Limit
- 34.53
- value
- 30.0
- group Id
- OG001
- lower Limit
- 12.95
- upper Limit
- 23.65
- value
- 17.8
- denoms
- counts
- group Id
- OG000
- value
- 443
- group Id
- OG001
- value
- 213
- units
- Participants
- description
- ORR was defined as the percentage of patients with at least one visit response of Complete Response (CR) or Partial Response (PR) per RECIST 1.1 for target lesions: CR: Disappearance of all target lesions; PR: \>=30% decrease in the sum of the longest diameter of target lesions; OR = CR + PR.
- 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 (which included all randomized patients) with measureable disease at baseline, analyzed on an ITT basis.
- reporting Status
- POSTED
- time Frame
- Tumor scans performed at baseline then every ~8 weeks up to 48 weeks, then every ~ 12 weeks thereafter until confirmed disease progression. Assessed until 22 Mar 2018 DCO; up to a maximum of approximately 4 years.
- title
- Objective Response Rate (ORR) Based on BICR Assesments According to RECIST 1.1
- type
- SECONDARY
- unit Of Measure
- Percentage of patients
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice