TriangleNCT01154140 · OUTCOME
Percentage of Participants With Disease Control at Week 12 Based on IRR
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
- Week 12
What was measured
Disease control rate at week 12 is defined as the percent of participants with CR, PR, or stable disease (SD) at week 12 according to RECIST v1.1 determined by IRR. The best response of SD would be assigned if SD criteria was met at least once after randomization at a minimum interval of 6 weeks. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions and disappearance of all non-target lesions. PR: \>=30% decrease taking as reference the baseline sum of lesion dimensions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.
Analysis population: The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.
Groups in this outcome
Crizotinib
Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
Chemotherapy
Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
| Group | Source count |
|---|---|
| Crizotinib | 172 |
| Chemotherapy | 171 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Crizotinib | 78.5 | Not reported | 71.6 | 84.4 | Not reported |
| Chemotherapy | 68.4 | Not reported | 60.9 | 75.3 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 19.4
- group Description
- The confidence interval for the difference in percentage was based on normal distribution.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0381
- param Type
- Difference in Percentage
- param Value
- 10.067
- statistical Method
- Pearson chi-square test
Complete source fields
- analyses
- ci Lower Limit
- 0.8
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 19.4
- group Description
- The confidence interval for the difference in percentage was based on normal distribution.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0381
- param Type
- Difference in Percentage
- param Value
- 10.067
- statistical Method
- Pearson chi-square test
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 71.6
- upper Limit
- 84.4
- value
- 78.5
- group Id
- OG001
- lower Limit
- 60.9
- upper Limit
- 75.3
- value
- 68.4
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 171
- units
- Participants
- description
- Disease control rate at week 12 is defined as the percent of participants with CR, PR, or stable disease (SD) at week 12 according to RECIST v1.1 determined by IRR. The best response of SD would be assigned if SD criteria was met at least once after randomization at a minimum interval of 6 weeks. CR: complete disappearance of all target lesions and non-target disease, with exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions and disappearance of all non-target lesions. PR: \>=30% decrease taking as reference the baseline sum of lesion dimensions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters. Short axis was used in sum for target nodes, while longest diameter was used in sum for all or target lesions. No clear progression of non-target disease. No new lesions.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Crizotinib 250 mg capsule, orally twice daily was administered in treatment cycle of 21 days. Participants could continue crizotinib treatment beyond the time of RECIST v1.1 defined PD, as determined by IRR, at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
- id
- OG000
- title
- Crizotinib
- description
- Standard doses of chemotherapy (pemetrexed/cisplatin or pemetrexed/carboplatin) were administered intravenously on Day 1 of each cycle for a maximum of 6 cycles. Pemetrexed 500 mg per meter square (m)\^2 IV infusion according to standard of care was administered over 10 min; either cisplatin 75 mg/m\^2 IV infusion was administered approximately 30 min after the end of the pemetrexed infusion or carboplatin was administered at a dose calculated to produce an AUC of 5 or 6 mg\*min/mL, approximately 30 min after end of pemetrexed infusion.
- id
- OG001
- title
- Chemotherapy
- param Type
- NUMBER
- population Description
- The FA population included all participants who were randomized with study treatment assignment designated according to the initial randomization.
- reporting Status
- POSTED
- time Frame
- Week 12
- title
- Percentage of Participants With Disease Control at Week 12 Based on IRR
- type
- SECONDARY
- unit Of Measure
- percentage of participants
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Preserved source evidence · Not medical advice