TriangleNCT01909453 · OUTCOME
Part 1: Number of Participants With Dermatologic-related Adverse Events of Special Interest (AESI) Graded According to the NCI-CTCAE v4.03
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- 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
AESI consisted of events for which there was a specific clinical interest with regard to LGX818 and/or MEK162 treatment. Dermatologic-related AESI included severe cutaneous adverse reactions, cutaneous non-squamous cell carcinoma, cutaneous squamous cell carcinoma, and melanomas. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/ prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. AESIs of grade 3 or 4 are reported in this outcome measure.
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
Severe cutaneous adverse reactions
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: LGX818 300 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Vemurafenib 960 mg BID | 5 | Not reported | Not reported | Not reported | Not reported |
Cutaneous squamous cell carcinoma
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: LGX818 300 mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Vemurafenib 960 mg BID | 13 | Not reported | Not reported | Not reported | Not reported |
Cutaneous non-squamous cell carcinoma
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 0 | Not reported | Not reported | Not reported | Not reported |
| Part 1: LGX818 300 mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Vemurafenib 960 mg BID | 1 | Not reported | Not reported | Not reported | Not reported |
Melanomas
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Part 1:LGX818 450 mg QD+MEK162 45 mg BID (Combo 450) | 1 | Not reported | Not reported | Not reported | Not reported |
| Part 1: LGX818 300 mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Part 1: Vemurafenib 960 mg BID | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 5
- title
- Severe cutaneous adverse reactions
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 13
- title
- Cutaneous squamous cell carcinoma
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 1
- title
- Cutaneous non-squamous cell carcinoma
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 2
- title
- Melanomas
- denoms
- counts
- group Id
- OG000
- value
- 192
- group Id
- OG001
- value
- 192
- group Id
- OG002
- value
- 186
- units
- Participants
- description
- AESI consisted of events for which there was a specific clinical interest with regard to LGX818 and/or MEK162 treatment. Dermatologic-related AESI included severe cutaneous adverse reactions, cutaneous non-squamous cell carcinoma, cutaneous squamous cell carcinoma, and melanomas. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/ prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. AESIs of grade 3 or 4 are reported in this outcome measure.
- 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
- COUNT_OF_PARTICIPANTS
- 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: Number of Participants With Dermatologic-related Adverse Events of Special Interest (AESI) Graded According to the NCI-CTCAE v4.03
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice