NCT01909453 · OUTCOME

Part 1: Number of Participants With Newly Occurring Notably Abnormal Vital Signs

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma · Source last updated 2026-02-27

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

Notably abnormal vital signs were: low/high systolic blood pressure (SBP) (millimeter of mercury \[mmHg\]): \<= 90 mmHg with decrease from baseline of \>= 20 mmHg/\>= 160 mmHg with increase from baseline of \>=20 mmHg. Low/high diastolic blood pressure (DBP) (mmHg): \<= 50 mmHg with decrease from baseline of \>=15 mmHg/\>=100 mmHg with increase from baseline of \>=15 mmHg. Low/high Pulse rate: \<=50 beats per minute (bpm) with decrease from baseline of \>=15 bpm/\>= 120 bpm with increase from baseline of \>=15 bpm. Low/high Weight (kilogram): \>=20 percent (%) decrease from baseline/\>= 10% increase from baseline. Low/high body temperature degree Celsius (C): \<= 36 degree C/\>= 37.5 degree C. Newly occurring was defined as participants not meeting criterion at baseline and meeting criterion post-baseline.

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. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at specified rows.

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.