TriangleNCT01283516 · OUTCOME
Overall Response Rate Based on Blinded Independent Review Committee (BIRC) Assessment
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
- 275 weeks
What was measured
Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).
Analysis population: Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.
Groups in this outcome
NSCLC With Prior ALKi (Arms 1A + 1B)
Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.
NSCLC ALKi Naive (Arm 2)
Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.
All NCSLC
all NSCLC patients.
| Group | Source count |
|---|---|
| NSCLC With Prior ALKi (Arms 1A + 1B) | 163 |
| NSCLC ALKi Naive (Arm 2) | 83 |
| All NCSLC | 246 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| NSCLC With Prior ALKi (Arms 1A + 1B) | 49.1 | Not reported | 41.2 | 57.0 | Not reported |
| NSCLC ALKi Naive (Arm 2) | 65.1 | Not reported | 53.8 | 75.2 | Not reported |
| All NCSLC | 54.5 | Not reported | 48.0 | 60.8 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 41.2
- upper Limit
- 57.0
- value
- 49.1
- group Id
- OG001
- lower Limit
- 53.8
- upper Limit
- 75.2
- value
- 65.1
- group Id
- OG002
- lower Limit
- 48.0
- upper Limit
- 60.8
- value
- 54.5
- denoms
- counts
- group Id
- OG000
- value
- 163
- group Id
- OG001
- value
- 83
- group Id
- OG002
- value
- 246
- units
- Participants
- description
- Overall response rate (ORR) was defined as the percentage of participants with a best overall complete response (CR) or partial response (PR) per RECIST 1.0. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI, CR was the disappearance of all target lesions. PR was at least a 30% decrease in the sum of the longest diameter of all target lesions, taking as reference the baseline sum of the longest diameters. Both CR and PR had to be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. CR = at least two determinations of CR, at least 4 weeks apart before progression. PR = at least two determinations of PR or better at least 4 weeks apart before progression (and not qualifying for a CR).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients with ALK-translocated NSCLC who were previously treated with an ALK inhibitor.
- id
- OG000
- title
- NSCLC With Prior ALKi (Arms 1A + 1B)
- description
- Patients with ALK-translocated NSCLC not previously treated with an ALK inhibitor.
- id
- OG001
- title
- NSCLC ALKi Naive (Arm 2)
- description
- all NSCLC patients.
- id
- OG002
- title
- All NCSLC
- param Type
- NUMBER
- population Description
- Full analysis set (FAS) - NSCLC: Subset of Full Analysis Set including ALK-positive NSCLC patients who received at least one dose of LDK378 in the 750 mg dose group.
- reporting Status
- POSTED
- time Frame
- 275 weeks
- title
- Overall Response Rate Based on Blinded Independent Review Committee (BIRC) Assessment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice