TriangleNCT00525148 · OUTCOME
Objective Response (OR) as Determined by RECIST 1.0
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
- Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.
What was measured
Objective response (OR) was assessed for all treated patients by independent review as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. OR included complete response (CR) and partial response (PR), where CR or PR must have been confirmed by a subsequent response in ≥28 days.
Analysis population: Treated set: The patients who had taken at least one dose of afatinib were included in the treated set.
Groups in this outcome
Afatinib
Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
| Group | Source count |
|---|---|
| Afatinib | 129 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Afatinib | 62.0 | Not reported | 53.1 | 70.4 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 53.1
- upper Limit
- 70.4
- value
- 62.0
- denoms
- counts
- group Id
- OG000
- value
- 129
- units
- Participants
- description
- Objective response (OR) was assessed for all treated patients by independent review as determined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.0. OR included complete response (CR) and partial response (PR), where CR or PR must have been confirmed by a subsequent response in ≥28 days.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
- id
- OG000
- title
- Afatinib
- param Type
- NUMBER
- population Description
- Treated set: The patients who had taken at least one dose of afatinib were included in the treated set.
- reporting Status
- POSTED
- time Frame
- Response assessment is done at end of Week 4 (after Course 1), Week 8 (after Course 2), Week 12 (after Course 3) and at 8-week intervals thereafter, up to 93 months.
- title
- Objective Response (OR) as Determined by RECIST 1.0
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice