TriangleNCT01539512 · OUTCOME
Overall Response Rate
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 17 months
What was measured
Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response. Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy. Partial response was defined as \>1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, \> 100000/μL platelets, \> 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors.
Analysis population: ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.
Groups in this outcome
Idelalisib + Rituximab
Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
Placebo + Rituximab
Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
| Group | Source count |
|---|---|
| Idelalisib + Rituximab | 110 |
| Placebo + Rituximab | 110 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Idelalisib + Rituximab | 74.5 | Not reported | 65.4 | 82.4 | Not reported |
| Placebo + Rituximab | 14.5 | Not reported | 8.5 | 22.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 65.4
- upper Limit
- 82.4
- value
- 74.5
- group Id
- OG001
- lower Limit
- 8.5
- upper Limit
- 22.5
- value
- 14.5
- denoms
- counts
- group Id
- OG000
- value
- 110
- group Id
- OG001
- value
- 110
- units
- Participants
- description
- Overall response rate was defined as the percentage of participants who achieved a best overall response of complete response or partial response. Complete response was defined as no lymphadenopathy, hepatomegaly, splenomegaly; normal complete blood count; confirmed by bone marrow aspirate \& biopsy. Partial response was defined as \>1 of the following criteria: a 50% decrease in peripheral blood lymphocytes, lymphadenopathy, liver size, spleen size; plus ≥ 1 of the following: ≥ 1500/μL absolute neutrophil count, \> 100000/μL platelets, \> 11.0 g/dL hemoglobin or 50% improvement for either of these parameters without transfusions or growth factors.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
- id
- OG000
- title
- Idelalisib + Rituximab
- description
- Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m\^2, and 500 mg/m\^2 thereafter)
- id
- OG001
- title
- Placebo + Rituximab
- param Type
- NUMBER
- population Description
- ITT Analysis Set: randomized participants with treatment group designated according to initial randomization.
- reporting Status
- POSTED
- time Frame
- Up to 17 months
- title
- Overall Response Rate
- type
- SECONDARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice