TriangleNCT01801111 · OUTCOME
Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants
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
- Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)
What was measured
Tumor response was assessed by IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments \>/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to \<10 mm. PR was defined as \>/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). The 95% CI was computed using Clopper-Pearson method.
Analysis population: Analysis was performed on RE population (IRC) participants who received prior chemotherapy.
Groups in this outcome
Alectinib
Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.
| Group | Source count |
|---|---|
| Alectinib | 96 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Alectinib | 44.8 | Not reported | 34.63 | 55.29 | Not reported |
Source statistical analyses
- ci Num Sides
- TWO_SIDED
- group Description
- Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.0599
- statistical Method
- Exact Clopper-Pearson CI
Complete source fields
- analyses
- ci Num Sides
- TWO_SIDED
- group Description
- Tests null hypothesis that the ORR is equal to 35% versus the alternative hypothesis that the objective response rate was not equal to 35%.
- group Ids
- OG000
- non Inferiority Type
- OTHER
- p Value
- 0.0599
- statistical Method
- Exact Clopper-Pearson CI
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 34.63
- upper Limit
- 55.29
- value
- 44.8
- denoms
- counts
- group Id
- OG000
- value
- 96
- units
- Participants
- description
- Tumor response was assessed by IRC according to RECIST v1.1. Objective response was defined as percentage of participants with a CR or PR that was confirmed by repeat assessments \>/=4 weeks after initial documentation. CR was defined as disappearance of all target, non-target lesions; normalization of tumor marker level; and reduction in all lymph nodes size to \<10 mm. PR was defined as \>/=30% decrease in the SoD of target lesions (taking as reference the baseline SoD). The 95% CI was computed using Clopper-Pearson method.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received alectinib at a dose of 600 mg via capsule, orally, twice daily, continuously starting on Day 1 Cycle 1 (in 28-day cycles) until PD, death, or withdrawal for any other reasons, whichever occurred first. After PD, participants were allowed to continue treatment with alectinib as per the discretion of the treating physician.
- id
- OG000
- title
- Alectinib
- param Type
- NUMBER
- population Description
- Analysis was performed on RE population (IRC) participants who received prior chemotherapy.
- reporting Status
- POSTED
- time Frame
- Baseline; assessments every 8 weeks post-baseline until progressive disease, unacceptable toxicity, consent withdrawal, death, other reason deemed by investigator, or last tumor assessment (up to approximately 2.5 years)
- title
- Percentage of Participants Achieving Objective Response (CR or PR) as Assessed by IRC in Chemotherapy-Pretreated Participants
- type
- PRIMARY
- unit Of Measure
- percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice