Trial Outcomes & Findings for Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer (NCT NCT01719380)
NCT ID: NCT01719380
Last Updated: 2021-06-23
Results Overview
DLTs were defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first 28 days of treatment and meets any of the criteria included blood and lymphatic system disorders, investigations (blood, renal, hepatic, metabolic), skin and subcutaneous tissue disorders: rash, HFSR (hand foot skin reaction) and/or photosensitivity, metabolism and nutrition disorders: hyperglycemia, gastrointestinal disorders, cardiac disorders, vascular disorders, general disorders and administration site conditions, tumor lysis syndrome, ophthalmologic and other adverse events: study drug-related fever, alkaline phosphatase elevation.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
Cycle 1: Day 1 to Day 28
Results posted on
2021-06-23
Participant Flow
This study was conducted in two phases Phase 1b and Phase 2. Phase 1b of the study was dose escalation phase to determine maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of LGX818 in combination with cetuximab (dual combination) and of LGX818 in combination with BYL719 and cetuximab (triple combination). Phase 2 of the study was to determine the clinical efficacy and safety of dual and triple combination in study participants.
Participant milestones
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
7
|
9
|
8
|
3
|
8
|
10
|
7
|
50
|
52
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
9
|
8
|
3
|
8
|
10
|
7
|
50
|
51
|
Reasons for withdrawal
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
2
|
0
|
1
|
0
|
1
|
4
|
3
|
|
Overall Study
Death
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
3
|
|
Overall Study
Participant/Guardian Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
6
|
5
|
6
|
3
|
7
|
10
|
6
|
39
|
42
|
|
Overall Study
Progressive Disease
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=7 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=50 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=52 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=115 Participants
|
6 Participants
n=24 Participants
|
32 Participants
n=42 Participants
|
38 Participants
n=42 Participants
|
107 Participants
n=42 Participants
|
|
Age, Customized
>=65 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
1 Participants
n=24 Participants
|
18 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
49 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
5 Participants
n=24 Participants
|
36 Participants
n=42 Participants
|
27 Participants
n=42 Participants
|
96 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
25 Participants
n=42 Participants
|
60 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Cycle 1: Day 1 to Day 28Population: The dose-determining set consisted of all participants from the phase 1b safety set who either met the following minimum exposure criterion and had scheduled safety evaluations or discontinued earlier due to DLT.
DLTs were defined as an adverse event (AE) or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurred within the first 28 days of treatment and meets any of the criteria included blood and lymphatic system disorders, investigations (blood, renal, hepatic, metabolic), skin and subcutaneous tissue disorders: rash, HFSR (hand foot skin reaction) and/or photosensitivity, metabolism and nutrition disorders: hyperglycemia, gastrointestinal disorders, cardiac disorders, vascular disorders, general disorders and administration site conditions, tumor lysis syndrome, ophthalmologic and other adverse events: study drug-related fever, alkaline phosphatase elevation.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=8 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=7 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=9 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=7 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Number of Participants With Incidence of Dose Limiting Toxicities (DLTs): Cycle 1
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From the date of randomization until the first documentation of disease progression or death due to any cause, censored date, whichever occurred first (maximum up to 43 months)Population: The full analysis set 2 (FAS2) comprised of all participants to whom study treatment was assigned by randomization.
PFS was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause. Participants who did not progress per RECIST (Response Evaluation Criteria in Solid Tumors) version (v) 1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=50 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=52 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Progression Free Survival (PFS)
|
4.2 months
Interval 3.0 to 5.1
|
4.9 months
Interval 4.0 to 7.1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From screening up to 30 days after the last dose of study treatment (for a maximum duration of 43 months, approximately)Population: The safety set included all participants from the full analysis set who received at least 1 dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least 1 valid post baseline safety assessment.
An AE was any untoward medical occurrence attributed to study drug in participants who received study drug. As per NCI-CTCAE v4.0, Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to study drug. Treatment-emergent AEs are between first dose of study drug and up to 30 days after last dose of study drug, that were absent before treatment or that worsened relative to pretreatment state. Number of participants with any Grade 3 or 4 treatment-emergent AE were reported in this outcome measure.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=7 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=50 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=52 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Treatment - Emergent Adverse Events of Grade 3 or 4 Severity Based on National Cancer Institute of Common Terminology Criteria (NCI-CTCAE), Version 4.0
|
2 Participants
|
4 Participants
|
6 Participants
|
7 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
33 Participants
|
43 Participants
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least one blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=6 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=8 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=5 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=6 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=4 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=15 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=15 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Plasma Clearance (CL/F) of LGX818 (Encorafenib)
|
16.8 liter per hour
Standard Deviation 3.60
|
11.7 liter per hour
Standard Deviation 6.10
|
12.1 liter per hour
Standard Deviation 5.95
|
12.3 liter per hour
Standard Deviation 4.96
|
7.69 liter per hour
Standard Deviation 3.13
|
14.2 liter per hour
Standard Deviation 5.75
|
14.1 liter per hour
Standard Deviation 3.65
|
17.8 liter per hour
Standard Deviation 17.4
|
13.1 liter per hour
Standard Deviation 5.07
|
10.9 liter per hour
Standard Deviation 5.70
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least one blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.
Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=6 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=28 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=36 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Plasma Clearance at Steady State (CL/F, ss) of LGX818 (Encorafenib)
Cycle 1 Day 8
|
—
|
—
|
—
|
—
|
17.0 liter per hour
Standard Deviation 3.42
|
24.4 liter per hour
Standard Deviation 18.3
|
15.4 liter per hour
Standard Deviation 4.25
|
22.4 liter per hour
Standard Deviation 17.7
|
—
|
—
|
|
Apparent Total Plasma Clearance at Steady State (CL/F, ss) of LGX818 (Encorafenib)
Cycle 2 Day 1
|
13.9 liter per hour
Standard Deviation 4.72
|
31.1 liter per hour
Standard Deviation 11.9
|
31.6 liter per hour
Standard Deviation 2.19
|
30.5 liter per hour
Standard Deviation 12.3
|
32.6 liter per hour
Standard Deviation 6.88
|
20.2 liter per hour
Standard Deviation 7.91
|
22.7 liter per hour
Standard Deviation 5.68
|
38.4 liter per hour
Standard Deviation 16.4
|
28.2 liter per hour
Standard Deviation 8.97
|
23.3 liter per hour
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=3 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=5 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=7 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=4 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Plasma Clearance (CL/F) of BYL719 (Alpelisib)
|
12.7 liter per hour
Standard Deviation 2.03
|
12.1 liter per hour
Standard Deviation 3.96
|
11.6 liter per hour
Standard Deviation 1.85
|
11.7 liter per hour
Standard Deviation 5.38
|
15.6 liter per hour
Standard Deviation 9.61
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.
Clearance of a drug at steady state is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=3 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=10 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=6 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=36 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Total Plasma Clearance at Steady State (CL/F, ss) of BYL719 (Alpelisib)
Cycle 2 Day 1
|
18.3 liter per hour
Standard Deviation 0.794
|
10.3 liter per hour
Standard Deviation 1.23
|
12.5 liter per hour
Standard Deviation 1.60
|
19.0 liter per hour
Standard Deviation 6.51
|
17.9 liter per hour
Standard Deviation 10.5
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Total Plasma Clearance at Steady State (CL/F, ss) of BYL719 (Alpelisib)
Cycle 1 Day 8
|
16.5 liter per hour
Standard Deviation 5.96
|
13.2 liter per hour
Standard Deviation 2.29
|
13.7 liter per hour
Standard Deviation 7.20
|
11.6 liter per hour
Standard Deviation 6.05
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=6 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=8 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=5 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=6 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=4 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=15 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=15 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Volume of Distribution (Vz/F) of LGX818 (Encorafenib)
|
104 liter
Standard Deviation 28.3
|
60.3 liter
Standard Deviation 25.8
|
62.8 liter
Standard Deviation 31.8
|
57.2 liter
Standard Deviation 29.6
|
49.2 liter
Standard Deviation 12.4
|
75.7 liter
Standard Deviation 31.6
|
64.6 liter
Standard Deviation 20.6
|
60.7 liter
Standard Deviation 44.0
|
63.5 liter
Standard Deviation 29.9
|
80.9 liter
Standard Deviation 93.9
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.
Volume of distribution at steady state is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=6 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=28 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=36 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of LGX818 (Encorafenib)
Cycle 1 Day 8
|
—
|
—
|
—
|
—
|
78.4 liter
Standard Deviation 13.0
|
98.2 liter
Standard Deviation 84.5
|
78.6 liter
Standard Deviation 26.2
|
88.8 liter
Standard Deviation 53.6
|
—
|
—
|
|
Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of LGX818 (Encorafenib)
Cycle 2 Day 1
|
66.8 liter
Standard Deviation 13.7
|
131 liter
Standard Deviation 45.8
|
110 liter
Standard Deviation 41.1
|
142 liter
Standard Deviation 84.5
|
137 liter
Standard Deviation 32.9
|
91.6 liter
Standard Deviation 41.4
|
102 liter
Standard Deviation 39.9
|
187 liter
Standard Deviation 89.5
|
117 liter
Standard Deviation 37.6
|
105 liter
Standard Deviation 42.2
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
Volume of distribution was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=3 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=5 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=7 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=4 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Volume of Distribution (Vz/F) of BYL719 (Alpelisib)
|
112 liter
Standard Deviation 22.0
|
104 liter
Standard Deviation 31.0
|
105 liter
Standard Deviation 34.3
|
106 liter
Standard Deviation 78.6
|
123 liter
Standard Deviation 50.7
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.
Volume of distribution at steady state was defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F, ss) is influenced by the fraction absorbed.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=3 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=10 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=6 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=36 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of BYL719 (Alpelisib)
Cycle 1 Day 8
|
110 liter
Standard Deviation 40.7
|
97.0 liter
Standard Deviation 20.6
|
105 liter
Standard Deviation 30.2
|
82.5 liter
Standard Deviation 18.8
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Apparent Terminal Volume of Distribution at Steady State (Vz/F, ss) of BYL719 (Alpelisib)
Cycle 2 Day 1
|
138 liter
Standard Deviation 20.7
|
75.4 liter
Standard Deviation 11.2
|
104 liter
Standard Deviation 10.7
|
144 liter
Standard Deviation 44.5
|
149 liter
Standard Deviation 100
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
Tmax was defined as the time to reach maximum observed plasma concentration of encorafenib.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=6 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=7 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=9 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=5 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=17 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=21 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of LGX818 (Encorafenib)
|
2.00 hour
Interval 1.98 to 2.02
|
1.99 hour
Interval 0.97 to 2.05
|
2.03 hour
Interval 1.0 to 4.0
|
2.17 hour
Interval 1.0 to 5.97
|
1.00 hour
Interval 0.98 to 1.98
|
2.02 hour
Interval 1.0 to 4.02
|
2.00 hour
Interval 0.87 to 5.95
|
3.87 hour
Interval 1.5 to 4.13
|
2.00 hour
Interval 0.93 to 6.12
|
2.03 hour
Interval 0.5 to 8.0
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.
Tmax, ss was defined as the time to reach maximum observed plasma concentration of LGX818 (encorafenib) at steady state.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=6 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=28 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=36 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of LGX818 (Encorafenib)
Cycle 2 Day 1
|
1.51 hour
Interval 1.0 to 2.02
|
2.00 hour
Interval 1.0 to 4.03
|
1.98 hour
Interval 0.97 to 4.0
|
1.98 hour
Interval 1.05 to 2.05
|
2.00 hour
Interval 1.0 to 2.02
|
2.02 hour
Interval 1.05 to 6.0
|
3.00 hour
Interval 1.92 to 7.98
|
2.27 hour
Interval 2.07 to 3.97
|
1.15 hour
Interval 0.98 to 5.93
|
2.00 hour
Interval 1.88 to 6.0
|
|
Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of LGX818 (Encorafenib)
Cycle 1 Day 8
|
—
|
—
|
—
|
—
|
0.98 hour
Interval 0.75 to 4.0
|
1.98 hour
Interval 1.0 to 3.98
|
2.00 hour
Interval 1.12 to 4.02
|
3.92 hour
Interval 0.5 to 4.08
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
Tmax was defined as the time to reach maximum observed plasma concentration of alpelisib.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=3 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=8 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=5 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=15 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of BYL719 (Alpelisib)
|
1.98 hour
Interval 0.98 to 2.0
|
3.97 hour
Interval 1.93 to 6.0
|
2.00 hour
Interval 0.87 to 5.95
|
2.10 hour
Interval 1.5 to 4.5
|
2.05 hour
Interval 1.92 to 8.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.
Tmax, ss was defined as the time to reach maximum observed plasma concentration of BYL719 (alpelisib) at steady state.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=3 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=10 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=6 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=36 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of BYL719 (Alpelisib)
Cycle 1 Day 8
|
1.97 hour
Interval 1.0 to 4.0
|
3.99 hour
Interval 1.0 to 7.97
|
2.15 hour
Interval 1.12 to 4.02
|
4.07 hour
Interval 0.0 to 4.1
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time to Reach Maximum Plasma Concentration at Steady State (Tmax, ss) of BYL719 (Alpelisib)
Cycle 2 Day 1
|
2.02 hour
Interval 1.0 to 4.0
|
4.00 hour
Interval 1.05 to 6.0
|
3.93 hour
Interval 2.0 to 5.98
|
4.03 hour
Interval 3.97 to 8.0
|
2.02 hour
Interval 1.0 to 6.0
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
T-last was defined as the time to reach last observed plasma concentration of encorafenib.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=6 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=7 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=9 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=5 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=17 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=21 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Last Observed Plasma Concentration (T-last) of LGX818 (Encorafenib)
|
23.98 hour
Interval 23.98 to 23.98
|
23.69 hour
Interval 8.0 to 24.0
|
24.03 hour
Interval 22.33 to 24.83
|
23.58 hour
Interval 8.8 to 24.13
|
23.00 hour
Interval 22.52 to 24.3
|
23.06 hour
Interval 7.97 to 24.22
|
22.02 hour
Interval 8.47 to 24.37
|
23.87 hour
Interval 8.23 to 25.92
|
23.85 hour
Interval 8.0 to 24.25
|
23.50 hour
Interval 5.38 to 24.5
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.
T-last, ss was defined as the time to reach last observed plasma concentration of encorafenib at steady state.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=6 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=28 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=36 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of LGX818 (Encorafenib)
Cycle 1 Day 8
|
—
|
—
|
—
|
—
|
23.78 hour
Interval 23.75 to 23.92
|
23.36 hour
Interval 7.58 to 23.98
|
23.92 hour
Interval 23.48 to 23.97
|
23.87 hour
Interval 21.83 to 23.95
|
—
|
—
|
|
Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of LGX818 (Encorafenib)
Cycle 2 Day 1
|
23.89 hour
Interval 23.88 to 23.9
|
22.13 hour
Interval 7.3 to 23.85
|
14.05 hour
Interval 6.0 to 24.67
|
23.45 hour
Interval 6.0 to 23.98
|
23.97 hour
Interval 7.25 to 24.2
|
23.08 hour
Interval 8.0 to 23.98
|
23.94 hour
Interval 7.0 to 24.38
|
23.42 hour
Interval 22.08 to 23.58
|
23.80 hour
Interval 8.07 to 24.17
|
23.42 hour
Interval 8.0 to 24.48
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
T-last was defined as the time to reach last observed plasma concentration of alpelisib.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=3 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=8 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=5 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=15 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Last Observed Plasma Concentration (T-last) of BYL719 (Alpelisib)
|
23.00 hour
Interval 22.52 to 24.3
|
23.06 hour
Interval 7.97 to 24.22
|
22.76 hour
Interval 8.47 to 24.37
|
23.87 hour
Interval 8.23 to 25.92
|
23.17 hour
Interval 7.92 to 24.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 8, Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'number analyzed' signifies number of participants evaluable for each specified category and 'Overall Number of Participants Analyzed' signifies number of participants with at least one PK sample analyzed.
T-last, ss was defined as the time to reach last observed plasma concentration of alpelisib at steady state.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=3 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=10 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=6 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=36 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of BYL719 (Alpelisib)
Cycle 1 Day 8
|
23.78 hour
Interval 23.75 to 23.92
|
23.36 hour
Interval 7.58 to 23.98
|
23.87 hour
Interval 7.75 to 23.97
|
23.87 hour
Interval 21.83 to 23.95
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Time of Last Observed Plasma Concentration at Steady State (T-last, ss) of BYL719 (Alpelisib)
Cycle 2 Day 1
|
23.97 hour
Interval 7.25 to 24.2
|
23.08 hour
Interval 8.0 to 23.98
|
23.94 hour
Interval 7.0 to 24.38
|
23.47 hour
Interval 22.08 to 23.58
|
23.77 hour
Interval 7.0 to 25.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
Ctrough, ss was defined as plasma trough concentration of encorafenib at steady state.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=5 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=6 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=6 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=1 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=11 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=15 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Trough Concentration at Steady State (Ctrough, ss) of LGX818 (Encorafenib)
|
9.87 nanogram per milliliter
Standard Deviation 6.69
|
20.5 nanogram per milliliter
Standard Deviation 28.0
|
15.7 nanogram per milliliter
Standard Deviation 22.0
|
20.6 nanogram per milliliter
Standard Deviation 18.4
|
7.69 nanogram per milliliter
Standard Deviation 1.76
|
10.4 nanogram per milliliter
Standard Deviation 5.05
|
26.5 nanogram per milliliter
Standard Deviation 31.4
|
29.2 nanogram per milliliter
Standard Deviation NA
Standard deviation was not estimated as only 1 participant was analyzed.
|
9.24 nanogram per milliliter
Standard Deviation 5.19
|
15.0 nanogram per milliliter
Standard Deviation 17.8
|
SECONDARY outcome
Timeframe: Cycle 2 Day 1: Pre-dose, 0.5, 1, 2, 4, 6, 8 and 24 +/- 2 hours post-dosePopulation: The PK analysis set consisted of all participants who had at least 1 blood sample providing evaluable PK data, received at least 1 dose of study drug, and experienced no major protocol deviations with relevant impact on the PK data. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
Ctrough, ss was defined as plasma trough concentration of alpelisib at steady state.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=3 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=8 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=1 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Plasma Trough Concentration at Steady State (Ctrough, ss) of BYL719 (Alpelisib)
|
36.7 nanogram per milliliter
Standard Deviation 21.0
|
108 nanogram per milliliter
Standard Deviation 41.1
|
283 nanogram per milliliter
Standard Deviation 156
|
66.0 nanogram per milliliter
Standard Deviation NA
Standard deviation was not estimable as only 1 participant was analyzed.
|
141 nanogram per milliliter
Standard Deviation 76.5
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first (up to 43 months)Population: The FAS1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2.
OS was defined as the time (in months) from the date of randomization or date of start of treatment to the date of death due to any cause or data censoring date, whichever occurred first. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=7 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=50 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=52 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Survival (OS)
|
15.0 months
Interval 14.8 to 15.2
|
5.4 months
Interval 1.2 to 7.8
|
NA months
Interval 2.9 to
Median and upper limit of 95% Confidence Interval (CI) were not estimable due to fewer participants with event.
|
16.6 months
Interval 3.9 to 23.5
|
6.6 months
Interval 5.0 to
Upper limit of 95% CI was not reached at the time of data cut-off.
|
8.7 months
Interval 3.8 to 27.1
|
9.8 months
Interval 3.7 to 25.2
|
NA months
Interval 5.3 to
Median and upper limit of 95% Confidence Interval (CI) were not estimable due to fewer participants with event.
|
9.3 months
Interval 5.8 to 15.6
|
8.5 months
Interval 6.1 to 15.2
|
SECONDARY outcome
Timeframe: From date of randomization or date of start of treatment until date of first documentation of PD or death due to any cause (maximum up to 43 months)Population: The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2.
Overall response rate as assessed by the investigator per RECIST v1.1, was defined as percentage of participants with a best overall response of complete response (CR) or partial response (PR), were recorded from date of randomization or date of start of treatment until date of first documentation of progressive disease (PD) or death due to any cause. CR was defined as complete disappearance of all target and non-nodal target lesions, and sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (\<) 10 millimeter (mm). PR defined as at least 30 percent (%) decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Only confirmed CR and PR are counted (those confirmed at least 4 weeks).
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=7 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=50 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=52 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Response Rate (ORR)
|
50.0 percentage of participants
Interval 1.3 to 98.7
|
14.3 percentage of participants
Interval 0.4 to 57.9
|
11.1 percentage of participants
Interval 0.3 to 48.2
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
25.0 percentage of participants
Interval 3.2 to 65.1
|
20.0 percentage of participants
Interval 2.5 to 55.6
|
0 percentage of participants
Interval 0.0 to 41.0
|
24.0 percentage of participants
Interval 13.1 to 38.2
|
26.9 percentage of participants
Interval 15.6 to 41.0
|
SECONDARY outcome
Timeframe: From the first documentation of OR (confirmed CR or PR) to first documentation of PD/death due to any cause or censoring date, whichever occurred first (up to 43 months)Population: The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
DOR: Time between date of the first documented response (CR or PR) and the date of first documented PD or death due to underlying cancer. If PD or death due to underlying cancer not occurred, then participant was censored at the date of last tumor assessment other than unknown. DOR was calculated for responders (confirmed) only. CR: Disappearance of all target, non-target lesions sustained for \>=4 weeks and any pathological lymph nodes reduced in short axis to \<10mm. PR: \>=30% decrease in sum of diameters of target lesions, taking as reference baseline sum of diameter. PD for target lesions: At least a 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study treatment, with absolute increase of \>=5 mm, or appearance of \>=1 new lesions. PD for non-target lesions: Unequivocal progression of pre-existing lesions/increase in overall tumor burden leading to discontinuation of therapy or appearance of new unequivocal malignant lesion.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=1 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=1 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=1 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=2 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=1 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=2 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=2 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=11 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=14 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Duration of Response (DOR)
|
10.6 months
CI values were not estimated due to single participant.
|
2.3 months
CI values were not estimated due to single participant.
|
21.7 months
CI values were not estimated due to single participant.
|
8.1 months
Interval 5.4 to 10.9
|
3.9 months
CI values were not estimated due to single participant.
|
3.6 months
Interval 2.8 to 4.4
|
3.3 months
Interval 2.8 to 3.8
|
—
|
5.6 months
Interval 2.0 to
Upper limit of 95% CI was not estimable due to low numbers of participant with events.
|
5.3 months
Interval 2.7 to 10.8
|
SECONDARY outcome
Timeframe: From the date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first (maximum up to 43 months)Population: The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b. The FAS2 comprised all randomized participants in Phase 2. Here 'Overall Number of Participants Analyzed' signifies number of participants who were evaluable for this outcome measure.
TTR as assessed by investigator according to RECIST v1.1, was defined as the time (in months) from date of randomization or date of start of treatment until first documented response (CR or PR) or data censoring date, whichever occurred first. CR was defined as complete disappearance of all target and non-target lesions sustained for at least 4 weeks apart before progression. Any pathological lymph nodes (whether target or non-target) reduced in short axis to \<10 mm. PR was defined as at least 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum diameters. Participants who did not achieve a confirmed PR or CR, were censored at last adequate tumor assessment date when they did not progress (including deaths not due to underlying disease) or at maximum follow-up (from study start to study end date) when participant had an event for progression-free survival.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=1 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=1 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=1 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=2 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=1 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=2 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=2 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=12 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=15 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Time to Response (TTR)
|
2.8 months
CI values were not estimated due to single participant.
|
1.4 months
CI values were not estimated due to single participant.
|
3.9 months
CI values were not estimated due to single participant.
|
4.0 months
Interval 1.4 to 6.7
|
1.5 months
CI values were not estimated due to single participant.
|
3.5 months
Interval 1.4 to 5.6
|
2.0 months
Interval 1.4 to 2.5
|
—
|
1.7 months
Interval 1.2 to 7.7
|
1.5 months
Interval 1.4 to 1.7
|
SECONDARY outcome
Timeframe: From date of start of treatment to the date of event defined as the first documented progression or death due to any cause, censored date, whichever occurred first (maximum up to 43 months)Population: The FAS 1 comprised all participants who received at least 1 full or partial dose of their assigned combination of study drugs during Phase 1b.
PFS was defined as the time from date of start of treatment to the date of event defined as the first documented progression or death due to any cause. Participants who did not progress per RECIST v1.1, were not known to have died prior to the data cut-off, or received any further anticancer therapy were censored at the date of last adequate tumor assessment or the anticancer therapy date, whichever was earlier.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 Participants
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 Participants
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 Participants
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 Participants
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 Participants
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=7 Participants
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 1b: Progression Free Survival (PFS)
|
12.0 months
Interval 10.6 to 13.4
|
3.7 months
Interval 1.2 to 4.1
|
2.8 months
Interval 1.3 to 4.3
|
12.0 months
Interval 1.8 to 12.3
|
5.4 months
Interval 4.4 to 9.1
|
4.3 months
Interval 3.8 to 13.6
|
4.1 months
Interval 1.7 to 5.8
|
4.2 months
Interval 2.9 to 12.3
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1)Population: The FAS2 comprised all randomized participants in Phase 2.
Gene alterations/expression relevant to the RAF/MEK/ERK (proto-oncogene serine/threonine-protein kinase/ mitogen-activated ERK kinase/ extracellular signal-regulated kinases) and EGFR/PI3K/AKT (epidermal growth factor receptor/ phosphatidylinositol 3-kinase/ protein kinase B) pathways in tumor tissue, baseline molecular status (mutation/amplification/expression) in tumor tissue of potential predictive markers of tumor response or resistance i.e. BRAF (v-raf murine sarcoma viral oncogene homolog B1), HRAS (harvey rat sarcoma protein), KRAS (V-Ki-ras2 kirsten rat sarcoma viral oncogene homolog B1), NRAS (neuroblastoma RAS viral oncogene homolog), PTEN (phosphatase and tensin homolog), PIK3CA (phosphatidylinositol 3-kinase gene), MAP2K1 (mitogen-activated protein kinase 1), MAP2K2 (mitogen-activated protein kinase 2), ARAF, c-MET, RAF1, EGFR was analyzed.
Outcome measures
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=50 Participants
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=52 Participants
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Phase 2: Number of Participants With Any Variant in Gene Status at Baseline
|
30 Participants
|
34 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Phase 1b: LGX818 100 mg + Cetuximab
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Phase 1b: LGX818 200 mg + Cetuximab
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 1b: LGX818 400 mg + Cetuximab
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase 1b: LGX818 450 mg + Cetuximab
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
Serious events: 5 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase 2: LGX818 200 mg + Cetuximab
Serious events: 25 serious events
Other events: 50 other events
Deaths: 0 deaths
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
Serious events: 33 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 participants at risk
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 participants at risk
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 participants at risk
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 participants at risk
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 participants at risk
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 participants at risk
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 participants at risk
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=7 participants at risk
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=50 participants at risk
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=52 participants at risk
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
9.6%
5/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Asthenia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Pyrexia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Lipase increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Product Issues
Thrombosis in device
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Female genital tract fistula
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Chorioretinopathy
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Gastrointestinal fistula
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Intestinal perforation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Gastrointestinal obstruction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Sepsis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Large intestinal haemorrhage
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Malaise
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Fatigue
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Chills
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Oedema
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Refractoriness to platelet transfusion
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Pelvic venous thrombosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
Other adverse events
| Measure |
Phase 1b: LGX818 100 mg + Cetuximab
n=2 participants at risk
Participants received 100 mg of LGX818 (encorafenib) orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until disease progression (PD), unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + Cetuximab
n=7 participants at risk
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 400 mg + Cetuximab
n=9 participants at risk
Participants received 400 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 450 mg + Cetuximab
n=8 participants at risk
Participants received 450 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 100 mg + Cetuximab
n=3 participants at risk
Participants received 200 mg of LGX818 along with 100 mg of BYL719 (alpelisib) orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 200 mg + Cetuximab
n=8 participants at risk
Participants received 200 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=10 participants at risk
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 1b: LGX818 300 mg + BYL719 200 mg + Cetuximab
n=7 participants at risk
Participants received 300 mg of LGX818 along with 200 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + Cetuximab
n=50 participants at risk
Participants received 200 mg of LGX818 orally once daily along with cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
Phase 2: LGX818 200 mg + BYL719 300 mg + Cetuximab
n=52 participants at risk
Participants received 200 mg of LGX818 along with 300 mg of BYL719 orally once daily and cetuximab orally once weekly in each cycle of 28 days continuously, until PD, unacceptable toxicity, withdrawal of informed consent or death, whichever occurred first. Participants were followed up to 30 days after last dose of study treatment (up to a maximum duration of 43 months).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Investigations
Vitamin D decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood sodium decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Troponin T increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
22.2%
2/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
57.1%
4/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
32.0%
16/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
36.5%
19/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
3/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
13.5%
7/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
42.9%
3/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
8.0%
4/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
21.2%
11/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.0%
6/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
19.2%
10/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
40.0%
4/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
57.1%
4/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
34.6%
18/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
7.7%
4/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
42.9%
3/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
24.0%
12/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
19.2%
10/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
3/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
16.0%
8/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
23.1%
12/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Eyelid irritation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
22.2%
2/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
16.0%
8/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
17.3%
9/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
38.0%
19/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.8%
15/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
8.0%
4/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
17.3%
9/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.5%
6/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial neoplasm
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
57.1%
4/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.5%
6/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
42.9%
3/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
22.2%
2/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
40.0%
4/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
18.0%
9/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
34.6%
18/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Headache
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
42.9%
3/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
3/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
34.0%
17/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
13/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.0%
6/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
7.7%
4/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
4/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
8.0%
4/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
13.5%
7/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Restless legs syndrome
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Product Issues
Thrombosis in device
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Psychiatric disorders
Hallucination
|
100.0%
2/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.0%
7/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
15.4%
8/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
42.9%
3/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
22.2%
2/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
16.0%
8/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
42.9%
3/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
16.0%
8/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
13.5%
7/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
42.9%
3/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
13.5%
7/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
8.0%
4/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
4/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
57.1%
4/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
18.0%
9/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.8%
15/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
4/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
18.0%
9/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
23.1%
12/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
22.2%
2/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
21.2%
11/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.0%
7/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
17.3%
9/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
7.7%
4/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
7.7%
4/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Onychomadesis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
9.6%
5/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
8.0%
4/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Aortic valve incompetence
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Diastolic dysfunction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Congenital, familial and genetic disorders
Distichiasis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Abnormal sensation in eye
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Chalazion
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Eye pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Glaucoma
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Myopia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Trichomegaly
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Accommodation disorder
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
8.0%
4/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
15.4%
8/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
7.7%
4/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Painful defaecation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Adverse event
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Chest discomfort
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Facial pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Gait disturbance
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Mucosal dryness
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Paronychia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
13.5%
7/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Abscess
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Lung infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Oral infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Viral infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Cardiac murmur
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
8.0%
4/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Food craving
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypophagia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
9.6%
5/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Ageusia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Psychiatric disorders
Fear
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at rest
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Bloody discharge
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Hypotension
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Varicose vein
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Retinopathy
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Blindness unilateral
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Diplopia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Eczema eyelids
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Erythema of eyelid
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
22.2%
2/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
16.0%
8/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
23.1%
12/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Pericardial effusion
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Dry eye
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
7.7%
4/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Eye irritation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Blepharitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Cataract
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Photopsia
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Uveitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Vision blurred
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Visual acuity reduced
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
55.6%
5/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
4/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
4/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
70.0%
7/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
42.9%
3/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
34.0%
17/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
48.1%
25/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
2/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
4/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
4/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
80.0%
8/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
71.4%
5/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
46.0%
23/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
57.7%
30/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
4/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
34.0%
17/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
40.4%
21/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
22.2%
2/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
4/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.0%
14/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.5%
6/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
3/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
4/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
87.5%
7/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
5/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
71.4%
5/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.0%
14/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
55.8%
29/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
22.2%
2/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
30.0%
3/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
34.6%
18/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Dry mouth
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Haemorrhoids
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Haematemesis
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Fatigue
|
100.0%
2/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
55.6%
5/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
62.5%
5/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
60.0%
6/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
42.9%
3/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
50.0%
25/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
51.9%
27/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Chills
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Malaise
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Pyrexia
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
42.9%
3/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
24.0%
12/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
21.2%
11/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Asthenia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
15.4%
8/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Oedema peripheral
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
9.6%
5/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Feeling cold
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Injection site reaction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
8.0%
4/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Tenderness
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Xerosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatobiliary disease
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatomegaly
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
22.2%
2/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.5%
6/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
22.2%
2/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Oral candidiasis
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Haemophilus bacteraemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Skin infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
44.4%
4/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Weight decreased
|
50.0%
1/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
37.5%
3/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
62.5%
5/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
30.0%
3/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
18.0%
9/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
36.5%
19/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
25.0%
2/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
7.7%
4/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
20.0%
2/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
9.6%
5/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
5/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
7.7%
4/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
33.3%
1/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
9.6%
5/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood iron decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Lipase increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
11.1%
1/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
10.0%
1/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
57.1%
4/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
32.0%
16/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
13.5%
7/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Amylase increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
28.6%
2/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.0%
6/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
14.3%
1/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.5%
1/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
6.0%
3/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Peritoneal adhesions
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Abdominal rigidity
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Enterovesical fistula
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Angular cheilitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Large intestinal ulcer
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
General physical health deterioration
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Face oedema
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Peripheral swelling
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Complication associated with device
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Early satiety
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
General disorders
Oedema
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Body tinea
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Skin candida
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Cystitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
7.7%
4/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Anal abscess
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Device related infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Gastric infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Incision site abscess
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Lip infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Localised infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Nail infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Infections and infestations
Wound infection
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Inflammation of wound
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Stoma site haemorrhage
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Vascular access complication
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Urine output decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood creatine increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood magnesium decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood phosphorus decreased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Eastern Cooperative Oncology Group performance status improved
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Investigations
Macular reflex abnormal
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral fibroma
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eye naevus
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Horner's syndrome
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Tremor
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Fine motor skill dysfunction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Polyuria
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Strangury
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Urethral pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Haematospermia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Nipple pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Vaginal inflammation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Reproductive system and breast disorders
Prostatism
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
12.0%
6/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
7.7%
4/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Cutaneous symptom
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hair disorder
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hirsutism
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Solar dermatitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Lipohypertrophy
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Precancerous skin lesion
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
5.8%
3/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Melanosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Onycholysis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin depigmentation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
Splinter haemorrhages
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Hot flush
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
4.0%
2/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Haematoma
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Pallor
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
2.0%
1/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Embolism
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
3.8%
2/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
|
Vascular disorders
Venous thrombosis limb
|
0.00%
0/2 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/9 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/3 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/8 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/10 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/7 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
0.00%
0/50 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
1.9%
1/52 • From screening up to 30 days after the last dose of study treatment (maximum up to 43 months)
Same event may appear as both AE and SAE. An event may be categorized as serious in 1 participant and non-serious in other, or participant may experience both SAE and non-SAE. The safety set included all participants from the FAS who received at least one dose of LGX818 (encorafenib), BYL719 (alpelisib) or cetuximab and had at least one valid post baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER