TriangleNCT03785964 · OUTCOME
Objective Response Rate Using RECIST Version 1.1 Criteria.
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- On the first day of every 3 cycles (each cycle is 28 days) through study completion, an average of 2 years
What was measured
Objective response rate (ORR) is defined as the proportion of participants having a confirmed Best Overall Response (BOR) of CR or PR by central reader using RECIST v1.1 criteria. Responses obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the assessment of ORR. However, any responses, which occurred after a new anticancer therapy was received, will not be included. ORR is presented by percentages of responders.
Analysis population: Intent-to-Treat Population (All Randomized)
Groups in this outcome
Double-Blind Phase - Nirogacestat
Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
Double-Blind Phase - Placebo
Placebo by mouth, twice daily Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet
| Group | Source count |
|---|---|
| Double-Blind Phase - Nirogacestat | 70 |
| Double-Blind Phase - Placebo | 72 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Double-Blind Phase - Nirogacestat | 41 | Not reported | 29.8 | 53.8 | Not reported |
| Double-Blind Phase - Placebo | 8 | Not reported | 3.1 | 17.3 | Not reported |
Source statistical analyses
- group Description
- Cochran-Mantel-Haenszel test for general association stratified by tumor location. Placebo was reference treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Two-sided p-value
- statistical Method
- Cochran-Mantel-Haenszel
Complete source fields
- analyses
- group Description
- Cochran-Mantel-Haenszel test for general association stratified by tumor location. Placebo was reference treatment.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- < 0.001
- p Value Comment
- Two-sided p-value
- statistical Method
- Cochran-Mantel-Haenszel
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 29.8
- upper Limit
- 53.8
- value
- 41
- group Id
- OG001
- lower Limit
- 3.1
- upper Limit
- 17.3
- value
- 8
- denoms
- counts
- group Id
- OG000
- value
- 70
- group Id
- OG001
- value
- 72
- units
- Participants
- description
- Objective response rate (ORR) is defined as the proportion of participants having a confirmed Best Overall Response (BOR) of CR or PR by central reader using RECIST v1.1 criteria. Responses obtained up until progression, or last evaluable assessment in the absence of progression, will be included in the assessment of ORR. However, any responses, which occurred after a new anticancer therapy was received, will not be included. ORR is presented by percentages of responders.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Nirogacestat 150 mg by mouth, twice daily Nirogacestat oral tablet: Nirogacestat tablet
- id
- OG000
- title
- Double-Blind Phase - Nirogacestat
- description
- Placebo by mouth, twice daily Placebo Oral Tablet: Sugar pill manufactured to mimic nirogacestat 50 mg tablet
- id
- OG001
- title
- Double-Blind Phase - Placebo
- param Type
- NUMBER
- population Description
- Intent-to-Treat Population (All Randomized)
- reporting Status
- POSTED
- time Frame
- On the first day of every 3 cycles (each cycle is 28 days) through study completion, an average of 2 years
- title
- Objective Response Rate Using RECIST Version 1.1 Criteria.
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice