TriangleNCT01909453 · OUTCOME
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
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
- Not reported
- Time frame
- Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
What was measured
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity; results in congenital anomaly/birth defect or an important medical event. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms; Grade 2: moderate; Grade 3: severe/medically significant; Grade 4: life-threatening consequence; Grade 5: death. AEs and SAEs of all grades combined were reported.
Analysis population: Safety analysis set included all participants who received at least one dose of study medication and have at least one valid post-baseline safety evaluation.
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 | 192 |
| Part 1: Vemurafenib 960 mg BID | 186 |
Reported measurements
Participants with AEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 98.4 | Not reported | Not reported | Not reported | Not reported |
| Part 1: LGX818 300 mg | 99.5 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Vemurafenib 960 mg BID | 100 | Not reported | Not reported | Not reported | Not reported |
Participants with SAEs
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 43.8 | Not reported | Not reported | Not reported | Not reported |
| Part 1: LGX818 300 mg | 37.0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Vemurafenib 960 mg BID | 41.9 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 98.4
- group Id
- OG001
- value
- 99.5
- group Id
- OG002
- value
- 100
- title
- Participants with AEs
- categories
- measurements
- group Id
- OG000
- value
- 43.8
- group Id
- OG001
- value
- 37.0
- group Id
- OG002
- value
- 41.9
- title
- Participants with SAEs
- denoms
- counts
- group Id
- OG000
- value
- 192
- group Id
- OG001
- value
- 192
- group Id
- OG002
- value
- 186
- units
- Participants
- description
- An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was any untoward medical occurrence at any dose that resulted in death; was life-threatening; required inpatient hospitalization/prolongation of existing hospitalization; resulted in persistent/significant disability/incapacity; results in congenital anomaly/birth defect or an important medical event. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms; Grade 2: moderate; Grade 3: severe/medically significant; Grade 4: life-threatening consequence; Grade 5: death. AEs and SAEs of all grades combined were reported.
- 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
- NUMBER
- population Description
- Safety analysis set included all participants who received at least one dose of study medication and have at least one valid post-baseline safety evaluation.
- reporting Status
- POSTED
- time Frame
- Baseline up to 30 days from last dose of study drug (up to 117.8 months of treatment exposure for LGX818+MEK162 45 mg [combo 450]; up to 111.4 months of treatment exposure for LGX818 300 mg; up to 110.5 months of treatment exposure for Vemurafenib 960 mg)
- title
- Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice