NCT01909453 · OUTCOME
Part 2: 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 after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)
What was measured
Notably abnormal vital signs were: low/high SBP (mmHg): \<= 90 mmHg with decrease from baseline of \>= 20 mmHg/\>= 160 mmHg with increase from baseline of \>=20 mmHg. Low/high 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 bpm with decrease from baseline of \>=15 bpm/\>= 120 bpm with increase from baseline of \>=15 bpm. Low/high Weight (kilogram): \>=20% decrease from baseline/\>= 10% increase from baseline. Low/high body temperature degree 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 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)
Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 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.
Part 2: 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 + Part 2: LGX818 300 mg
Participants of Part 1 and 2 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, and 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.
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 256 |
|---|
| Part 2: LGX818 300 mg | 80 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 264 |
|---|
Reported measurements
Sitting Pulse Rate (bpm): High
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 252 |
|---|
| Part 2: LGX818 300 mg | 78 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 262 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: LGX818 300 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2: LGX818 300 mg | 10 | Not reported | Not reported | Not reported | Not reported |
|---|
Sitting Pulse Rate (bpm): Low
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 254 |
|---|
| Part 2: LGX818 300 mg | 77 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 258 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 16 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: LGX818 300 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2: LGX818 300 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Sitting Systolic Blood Pressure (mmHg): High
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 243 |
|---|
| Part 2: LGX818 300 mg | 76 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 253 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 51 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: LGX818 300 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2: LGX818 300 mg | 22 | Not reported | Not reported | Not reported | Not reported |
|---|
Sitting Systolic Blood Pressure (mmHg): Low
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 255 |
|---|
| Part 2: LGX818 300 mg | 78 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 262 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 15 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: LGX818 300 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2: LGX818 300 mg | 9 | Not reported | Not reported | Not reported | Not reported |
|---|
Sitting Diastolic Blood Pressure (mmHg): High
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 253 |
|---|
| Part 2: LGX818 300 mg | 78 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 261 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 49 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: LGX818 300 mg | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2: LGX818 300 mg | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
Sitting Diastolic Blood Pressure (mmHg): Low
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 255 |
|---|
| Part 2: LGX818 300 mg | 77 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 262 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 12 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: LGX818 300 mg | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2: LGX818 300 mg | 13 | Not reported | Not reported | Not reported | Not reported |
|---|
Weight (kg): High
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 256 |
|---|
| Part 2: LGX818 300 mg | 80 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 264 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 58 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: LGX818 300 mg | 3 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2: LGX818 300 mg | 14 | Not reported | Not reported | Not reported | Not reported |
|---|
Weight (kg): Low
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 256 |
|---|
| Part 2: LGX818 300 mg | 80 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 264 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: LGX818 300 mg | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2: LGX818 300 mg | 11 | Not reported | Not reported | Not reported | Not reported |
|---|
Body temperature (degree C): High
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 252 |
|---|
| Part 2: LGX818 300 mg | 77 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 253 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 24 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: LGX818 300 mg | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2: LGX818 300 mg | 19 | Not reported | Not reported | Not reported | Not reported |
|---|
Body temperature (degree C): Low
Analysis denominator · Participants
| Group | Source count |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 201 |
|---|
| Part 2: LGX818 300 mg | 55 |
|---|
| Part 1 + Part 2: LGX818 300 mg | 189 |
|---|
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300) | 128 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 2: LGX818 300 mg | 23 | Not reported | Not reported | Not reported | Not reported |
|---|
| Part 1 + Part 2: LGX818 300 mg | 98 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 10
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 252
- group Id
- OG001
- value
- 78
- group Id
- OG002
- value
- 262
- units
- Participants
- title
- Sitting Pulse Rate (bpm): High
- categories
- measurements
- group Id
- OG000
- value
- 16
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 254
- group Id
- OG001
- value
- 77
- group Id
- OG002
- value
- 258
- units
- Participants
- title
- Sitting Pulse Rate (bpm): Low
- categories
- measurements
- group Id
- OG000
- value
- 51
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 22
- denoms
- counts
- group Id
- OG000
- value
- 243
- group Id
- OG001
- value
- 76
- group Id
- OG002
- value
- 253
- units
- Participants
- title
- Sitting Systolic Blood Pressure (mmHg): High
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 9
- denoms
- counts
- group Id
- OG000
- value
- 255
- group Id
- OG001
- value
- 78
- group Id
- OG002
- value
- 262
- units
- Participants
- title
- Sitting Systolic Blood Pressure (mmHg): Low
- categories
- measurements
- group Id
- OG000
- value
- 49
- group Id
- OG001
- value
- 6
- group Id
- OG002
- value
- 14
- denoms
- counts
- group Id
- OG000
- value
- 253
- group Id
- OG001
- value
- 78
- group Id
- OG002
- value
- 261
- units
- Participants
- title
- Sitting Diastolic Blood Pressure (mmHg): High
- categories
- measurements
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 13
- denoms
- counts
- group Id
- OG000
- value
- 255
- group Id
- OG001
- value
- 77
- group Id
- OG002
- value
- 262
- units
- Participants
- title
- Sitting Diastolic Blood Pressure (mmHg): Low
- categories
- measurements
- group Id
- OG000
- value
- 58
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 14
- denoms
- counts
- group Id
- OG000
- value
- 256
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 264
- units
- Participants
- title
- Weight (kg): High
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 256
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 264
- units
- Participants
- title
- Weight (kg): Low
- categories
- measurements
- group Id
- OG000
- value
- 24
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 19
- denoms
- counts
- group Id
- OG000
- value
- 252
- group Id
- OG001
- value
- 77
- group Id
- OG002
- value
- 253
- units
- Participants
- title
- Body temperature (degree C): High
- categories
- measurements
- group Id
- OG000
- value
- 128
- group Id
- OG001
- value
- 23
- group Id
- OG002
- value
- 98
- denoms
- counts
- group Id
- OG000
- value
- 201
- group Id
- OG001
- value
- 55
- group Id
- OG002
- value
- 189
- units
- Participants
- title
- Body temperature (degree C): Low
- denoms
- counts
- group Id
- OG000
- value
- 256
- group Id
- OG001
- value
- 80
- group Id
- OG002
- value
- 264
- units
- Participants
- description
- Notably abnormal vital signs were: low/high SBP (mmHg): \<= 90 mmHg with decrease from baseline of \>= 20 mmHg/\>= 160 mmHg with increase from baseline of \>=20 mmHg. Low/high 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 bpm with decrease from baseline of \>=15 bpm/\>= 120 bpm with increase from baseline of \>=15 bpm. Low/high Weight (kilogram): \>=20% decrease from baseline/\>= 10% increase from baseline. Low/high body temperature degree C: \<= 36 degree C/\>= 37.5 degree C. Newly occurring was defined as participants not meeting criterion at baseline and meeting criterion post-baseline.
- groups
- description
- Participants received 300 mg of LGX818 orally once daily along with 45 mg of MEK162 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
- OG000
- title
- Part 2: LGX818 300 mg QD+MEK162 45 mg BID (Combo 300)
- 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 2: LGX818 300 mg
- description
- Participants of Part 1 and 2 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, and study discontinuation, lost to follow-up or death.
- id
- OG002
- title
- Part 1 + Part 2: LGX818 300 mg
- 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. Here, "Overall Number of Participants Analyzed" signifies number of participants evaluable for this outcome measure and "Number analyzed" signifies participants evaluable at specified rows.
- reporting Status
- POSTED
- time Frame
- Baseline up to 30 days after last dose of study drug (up to 106.3 M of treatment exposure for Part 2: LGX818+MEK162 45 mg; up to 98.4 M of treatment exposure for Part 2: LGX818 300 mg; up to 111.4 M of treatment exposure for Part 1+Part 2: LGX818 300 mg)
- title
- Part 2: Number of Participants With Newly Occurring Notably Abnormal Vital Signs
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice
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