TriangleNCT01909453 · OUTCOME
Part 1: 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 until censoring date/death, whichever occurred first (up to 117.8 months [M] of treatment exposure for LGX818 +MEK162; up to 111.4 months of treatment exposure for LGX818; up to 110.5 months of treatment exposure for Vemurafenib)
What was measured
Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a death was not observed by the date of analysis cutoff, OS was censored at the date of last contact.
Analysis population: FAS included all randomized participants.
Groups in this outcome
Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
Part 1: LGX818 300 mg
Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
Part 1: Vemurafenib 960 mg BID
Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
| Group | Source count |
|---|---|
| Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 192 |
| Part 1: LGX818 300 mg | 194 |
| Part 1: Vemurafenib 960 mg BID | 191 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 33.6 | Not reported | 24.4 | 39.2 | Not reported |
| Part 1: LGX818 300 mg | 23.5 | Not reported | 19.6 | 33.6 | Not reported |
| Part 1: Vemurafenib 960 mg BID | 16.9 | Not reported | 14.0 | 24.5 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 24.4
- upper Limit
- 39.2
- value
- 33.6
- group Id
- OG001
- lower Limit
- 19.6
- upper Limit
- 33.6
- value
- 23.5
- group Id
- OG002
- lower Limit
- 14.0
- upper Limit
- 24.5
- value
- 16.9
- denoms
- counts
- group Id
- OG000
- value
- 192
- group Id
- OG001
- value
- 194
- group Id
- OG002
- value
- 191
- units
- Participants
- description
- Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a death was not observed by the date of analysis cutoff, OS was censored at the date of last contact.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 450 milligram (mg) of LGX818 orally once daily (QD) along with 45 mg of MEK162 twice daily (BID) for each 28 day treatment cycle until progressive disease (PD) as confirmed by Blinded Independent Review Committee (BIRC), withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
- id
- OG000
- title
- Part 1: LGX818 450 mg QD+MEK162 45 mg BID (Combo 450)
- description
- Participants received 300 mg of LGX818 orally once daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
- id
- OG001
- title
- Part 1: LGX818 300 mg
- description
- Participants received 960 mg of Vemurafenib according to the locally approved prescribing information twice daily for each 28 day treatment cycle until PD as confirmed by BIRC, withdrawal of consent, intolerable toxicity, study discontinuation, lost to follow-up or death.
- id
- OG002
- title
- Part 1: Vemurafenib 960 mg BID
- param Type
- MEDIAN
- population Description
- FAS included all randomized participants.
- reporting Status
- POSTED
- time Frame
- From randomization until censoring date/death, whichever occurred first (up to 117.8 months [M] of treatment exposure for LGX818 +MEK162; up to 111.4 months of treatment exposure for LGX818; up to 110.5 months of treatment exposure for Vemurafenib)
- title
- Part 1: Overall Survival (OS)
- type
- SECONDARY
- unit Of Measure
- Months
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice