TriangleNCT01889186 · OUTCOME
Overall Response Rate (Main Cohort)
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
- Up to 36 weeks
What was measured
The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission \[CR\] + complete remission with incomplete marrow recovery \[CRi\] + nodular partial remission \[nPR\] + partial remission \[PR\]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria as assessed by the Independent Review Committee (IRC) in the first 70 participants treated in the Main Cohort.
Analysis population: The first 70 participants who were treated with ABT-199 in the Main Cohort
Groups in this outcome
Main Cohort
Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
| Group | Source count |
|---|---|
| Main Cohort | 70 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Main Cohort | 77.1 | Not reported | 65.6 | 86.3 | Not reported |
Source statistical analyses
- group Description
- The ORR for ABT-199 was tested to reject the null hypothesis of ORR = 40%. If the null hypothesis is rejected and the ORR is higher than 40%, then ABT-199 has been shown to have an ORR significantly higher than 40%.The p-value is from the exact binomial distribution comparing ABT-199 ORR to the 40% historical control rate.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Method
- Clopper-Pearson exact method
Complete source fields
- analyses
- group Description
- The ORR for ABT-199 was tested to reject the null hypothesis of ORR = 40%. If the null hypothesis is rejected and the ORR is higher than 40%, then ABT-199 has been shown to have an ORR significantly higher than 40%.The p-value is from the exact binomial distribution comparing ABT-199 ORR to the 40% historical control rate.
- group Ids
- OG000
- non Inferiority Type
- SUPERIORITY
- p Value
- <0.001
- statistical Method
- Clopper-Pearson exact method
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 65.6
- upper Limit
- 86.3
- value
- 77.1
- denoms
- counts
- group Id
- OG000
- value
- 70
- units
- Participants
- description
- The overall response rate (ORR) is defined as the proportion of participants with an overall response (complete remission \[CR\] + complete remission with incomplete marrow recovery \[CRi\] + nodular partial remission \[nPR\] + partial remission \[PR\]) per the 2008 Modified International Workshop for Chronic Lymphocytic Leukemia (IWCLL)/National Cancer Institute-Working Group (NCI-CWG) criteria as assessed by the Independent Review Committee (IRC) in the first 70 participants treated in the Main Cohort.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received ABT-199 tablets once daily (QD) orally for up to 79 months. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg.
- id
- OG000
- title
- Main Cohort
- param Type
- NUMBER
- population Description
- The first 70 participants who were treated with ABT-199 in the Main Cohort
- reporting Status
- POSTED
- time Frame
- Up to 36 weeks
- title
- Overall Response Rate (Main Cohort)
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice