TriangleNCT01154140 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- months
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- From randomization to death or last date known alive for those not known to have died (up to 72 months)
What was measured
OS (in months) was defined as the duration from start of study treatment to date of death due to any cause. OS = (date of death minus the date of randomization of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.
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 | NA | Not reported | 45.8 | NA | Median and upper limit of 95% CI were not estimable due to the small number of participants who had event. |
| Chemotherapy | 47.5 | Not reported | 32.2 | NA | Upper limit of 95% CI was not estimable due to the small number of participants who had event. |
Source statistical analyses
- ci Lower Limit
- 0.548
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.053
- estimate Comment
- HR was calculated based on the Cox Proportional hazards model stratified by ECOG PS, race group, and brain metastases. Assuming proportional hazards, a hazard ratio (less than)\<1 indicates a reduction in hazard rate in favor of crizotinib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0489
- p Value Comment
- P-value was obtained from 1-sided log rank test, stratified by ECOG PS, race group and brain metastases.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.760
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.548
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 1.053
- estimate Comment
- HR was calculated based on the Cox Proportional hazards model stratified by ECOG PS, race group, and brain metastases. Assuming proportional hazards, a hazard ratio (less than)\<1 indicates a reduction in hazard rate in favor of crizotinib.
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY_OR_OTHER
- p Value
- 0.0489
- p Value Comment
- P-value was obtained from 1-sided log rank test, stratified by ECOG PS, race group and brain metastases.
- param Type
- Hazard Ratio (HR)
- param Value
- 0.760
- statistical Method
- Log Rank
- classes
- categories
- measurements
- comment
- Median and upper limit of 95% CI were not estimable due to the small number of participants who had event.
- group Id
- OG000
- lower Limit
- 45.8
- upper Limit
- NA
- value
- NA
- comment
- Upper limit of 95% CI was not estimable due to the small number of participants who had event.
- group Id
- OG001
- lower Limit
- 32.2
- upper Limit
- NA
- value
- 47.5
- denoms
- counts
- group Id
- OG000
- value
- 172
- group Id
- OG001
- value
- 171
- units
- Participants
- description
- OS (in months) was defined as the duration from start of study treatment to date of death due to any cause. OS = (date of death minus the date of randomization of study medication plus 1) divided by 30.4. For participants who were alive, overall survival was censored on last date the participants were known to be alive.
- 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
- MEDIAN
- 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
- From randomization to death or last date known alive for those not known to have died (up to 72 months)
- title
- Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice