Trial Outcomes & Findings for A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma (NCT NCT01801358)
NCT ID: NCT01801358
Last Updated: 2020-09-16
Results Overview
A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
38 participants
Primary outcome timeframe
Cycle 1 (up to 28 days)
Results posted on
2020-09-16
Participant Flow
The CMEK162X2203 study began recruitment on 26-Aug-2013 and concluded on 15-May-2015. Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.
Participant Flow and Baseline Demographics data represents the Full Analysis Set (FAS), which includes all patients who received at least one full or partial dose of sotrastaurin or binimetinib. Not completed subjects represents subjects that stopped treatment early, due to the corresponding reason.
Participant milestones
| Measure |
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
8
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
6
|
6
|
8
|
Reasons for withdrawal
| Measure |
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
2
|
1
|
0
|
0
|
1
|
|
Overall Study
Physician Decision
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
6
|
4
|
4
|
5
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
2
|
Baseline Characteristics
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
Baseline characteristics by cohort
| Measure |
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Total
n=38 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Age, Continuous
|
48.7 years
STANDARD_DEVIATION 15.21 • n=5 Participants
|
57.0 years
STANDARD_DEVIATION 10.43 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 10.82 • n=5 Participants
|
59.8 years
STANDARD_DEVIATION 9.11 • n=4 Participants
|
56.8 years
STANDARD_DEVIATION 10.87 • n=21 Participants
|
61.5 years
STANDARD_DEVIATION 10.65 • n=10 Participants
|
56.4 years
STANDARD_DEVIATION 11.39 • n=115 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
14 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
24 Participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
6 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Russian
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
1 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
10 participants
n=115 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
4 participants
n=21 Participants
|
8 participants
n=10 Participants
|
21 participants
n=115 Participants
|
|
Region of Enrollment
Netherlands
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
2 participants
n=10 Participants
|
5 participants
n=115 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
2 participants
n=21 Participants
|
0 participants
n=10 Participants
|
7 participants
n=115 Participants
|
|
Region of Enrollment
United Kingdom
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
2 participants
n=115 Participants
|
|
Region of Enrollment
France
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=10 Participants
|
7 participants
n=115 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
6 participants
n=10 Participants
|
11 participants
n=115 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
6 participants
n=115 Participants
|
|
Baseline WHO Performance Status
0:
|
3 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
5 participants
n=21 Participants
|
8 participants
n=10 Participants
|
32 participants
n=115 Participants
|
|
Baseline WHO Performance Status
1:
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
1 participants
n=4 Participants
|
1 participants
n=21 Participants
|
0 participants
n=10 Participants
|
6 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (up to 28 days)Population: Analysis is comprised of the Dose-determining Set, which is all patients from the safety set who either met the minimum exposure criterion below and had sufficient safety evaluations during Cycle 1, or discontinued earlier due to DLT during Cycle 1.
A DLT is defined as an adverse event or abnormal laboratory value as defined in the protocol that is assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 28 days of treatment with AEB071 and MEK162.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Anaemia
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
1 DLTs
|
0 DLTs
|
—
|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Diarrhoea
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
2 DLTs
|
1 DLTs
|
0 DLTs
|
—
|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Fatigue
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
1 DLTs
|
1 DLTs
|
0 DLTs
|
—
|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Vomiting
|
1 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
1 DLTs
|
1 DLTs
|
—
|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Nausea
|
1 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
1 DLTs
|
0 DLTs
|
—
|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
General Physical Health Deterioration
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
1 DLTs
|
0 DLTs
|
0 DLTs
|
—
|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Malaise
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
1 DLTs
|
0 DLTs
|
—
|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Blood Creatinine Increased
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
1 DLTs
|
—
|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Ejection Fraction Decreased
|
1 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
—
|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Dermatitis Acneiform
|
0 DLTs
|
0 DLTs
|
2 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
—
|
|
Phase Ib: Incidence of Dose Limiting Toxicities (DLT) During the First Cycle
Rash
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
0 DLTs
|
1 DLTs
|
0 DLTs
|
—
|
PRIMARY outcome
Timeframe: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)The time from date of randomization to the date of event defined as the first documented progression or death due to any cause. Due to an enrollment halt, the Phase II part of the study was not conducted. The sponsor decided to permanently stop recruitment for the study prior to MTD determination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)Population: Analysis group consists of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
An adverse event is defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s) that occur after patient's signed informed consent has been obtained.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase Ib/II: The Number of Subjects Experiencing At Least One Adverse Event (AE)
|
8 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
6 participants
|
—
|
SECONDARY outcome
Timeframe: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)Population: Analysis group is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
Serious adverse event (SAE) is defined as one of the following: * Is fatal or life-threatening * Results in persistent or significant disability/incapacity * Constitutes a congenital anomaly/birth defect * Is medically significant * Requires inpatient hospitalization or prolongation of existing hospitalization * Note that hospitalizations for the following reasons should not be reported as serious adverse events: * Routine treatment or monitoring of the studied indication, not associated with any deterioration in condition * Elective or pre-planned treatment for a pre-existing condition that is unrelated to metastatic uveal melanoma and has not worsened since signing the informed consent * Social reasons and respite care in the absence of any deterioration in the patient's general condition
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase Ib/II: The Number of Subjects Experiencing At Least One Serious Adverse Event (SAE)
|
6 participants
|
3 participants
|
1 participants
|
3 participants
|
4 participants
|
2 participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (up to 28 days)Population: Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Stable Disease
|
5 participants
|
5 participants
|
4 participants
|
4 participants
|
2 participants
|
3 participants
|
—
|
|
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Complete Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Partial Response
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
—
|
|
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Progressive disease
|
2 participants
|
1 participants
|
2 participants
|
1 participants
|
2 participants
|
3 participants
|
—
|
|
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Best Overall Response (BOR)
Unknown
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (up to 28 days)Population: Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination. Duration of Response (DOR) is not reported, since there were no responses of Complete Response (CR) or Partial Response (PR) at any time during the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 (up to 28 days)Population: Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.
Assessment of the preliminary anti-tumor activity of AEB071 and MEK162 in combination. PFS is the time from date of randomization/start of treatment to the date of event defined as the first documented progression or death due to any cause.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase Ib: Assessment of The Preliminary Anti-tumor Activity - Progression Free Survival (PFS)
|
3.8 weeks
Interval 1.9 to 11.5
|
3.6 weeks
Interval 3.2 to 3.7
|
3.4 weeks
Interval 1.6 to 3.7
|
4 weeks
Interval 1.7 to 6.5
|
3.7 weeks
Interval 1.2 to 5.3
|
3.1 weeks
Interval 1.8 to 5.4
|
—
|
SECONDARY outcome
Timeframe: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)Population: Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone. Overall response rate (ORR) is the proportion of patients with a best overall response of Complete Response (CR) or Partial Response (PR). This is also referred to as 'Objective response rate' in some protocols or publications. Due to an enrollment halt, the Phase II part of the study was not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)Population: Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Due to an enrollment halt, the Phase II part of the study was not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)Population: Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone. Duration of Response is not reported, due to the enrollment halt, which occurred prior to Phase II of the study.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose of Cycle 1, Day 1 (C1D1) to time to progression (up to 18 months from Last Patient First Visit)Population: Analysis group is comprised of the Full Analysis Set (FAS), which is all patients in the phase Ib part of the study who received at least one full or partial dose of AEB071 or MEK162.
Evaluation of the preliminary anti-tumor activity at the RP2D for AEB071 and MEK162 and at 45 mg BID for MEK162 alone. Overall survival (OS) is defined as the time from date of randomization/start of treatment to date of death due to any cause. Due to an enrollment halt, the Phase II part of the study was not conducted.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Cycle 1 (Day 1)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 1)
|
15217.1 hr*ng/ml
Geometric Coefficient of Variation 71.48
|
7448.5 hr*ng/ml
Geometric Coefficient of Variation 46.34
|
7136 hr*ng/ml
Geometric Coefficient of Variation 25.09
|
15090 hr*ng/ml
Geometric Coefficient of Variation 53.89
|
14051.2 hr*ng/ml
Geometric Coefficient of Variation 45.83
|
18840.8 hr*ng/ml
Geometric Coefficient of Variation 36.24
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 1)
|
3768.7 ng/ml
Geometric Coefficient of Variation 57.12
|
1837.5 ng/ml
Geometric Coefficient of Variation 35.9
|
1932.5 ng/ml
Geometric Coefficient of Variation 31.18
|
2968.1 ng/ml
Geometric Coefficient of Variation 58.32
|
2813 ng/ml
Geometric Coefficient of Variation 36.83
|
4459 ng/ml
Geometric Coefficient of Variation 26.45
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 1)
|
2.1 hr
Interval 0.5 to 5.8
|
1.6 hr
Interval 0.4 to 4.0
|
1.1 hr
Interval 1.0 to 4.0
|
1.5 hr
Interval 0.5 to 2.0
|
1 hr
Interval 0.5 to 1.9
|
1 hr
Interval 1.0 to 2.0
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 15)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=2 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase Ib: PK Parameters for AEB071 - AUC0-8hr (Cycle 1; Day 15)
|
20629.7 hr*ng/ml
Geometric Coefficient of Variation 11.81
|
5879.9 hr*ng/ml
Geometric Coefficient of Variation 32.46
|
6330.3 hr*ng/ml
Geometric Coefficient of Variation 29.28
|
16737.1 hr*ng/ml
Geometric Coefficient of Variation 17.56
|
15313.6 hr*ng/ml
Geometric Coefficient of Variation 105.21
|
15055.5 hr*ng/ml
Geometric Coefficient of Variation 78.89
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 15)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=2 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase lb: PK Parameters for AEB071 - Cmax (Cycle 1; Day 15)
|
3716.5 ng/ml
Geometric Coefficient of Variation 23.72
|
1244.6 ng/ml
Geometric Coefficient of Variation 27.5
|
1347.1 ng/ml
Geometric Coefficient of Variation 28.56
|
3065.6 ng/ml
Geometric Coefficient of Variation 60.1
|
3263.8 ng/ml
Geometric Coefficient of Variation 96.11
|
3597.2 ng/ml
Geometric Coefficient of Variation 62.84
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 15)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=2 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase lb: PK Parameters for AEB071 - Tmax (Cycle 1; Day 15)
|
2.1 hr
Interval 2.0 to 8.0
|
2 hr
Interval 1.1 to 8.3
|
1.5 hr
Interval 0.5 to 2.0
|
2.6 hr
Interval 1.0 to 4.2
|
3.9 hr
Interval 2.0 to 4.2
|
1.9 hr
Interval 0.5 to 2.1
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 1)
|
962 hr*ng/ml
Geometric Coefficient of Variation 50.15
|
1587.7 hr*ng/ml
Geometric Coefficient of Variation 55.75
|
1496.7 hr*ng/ml
Geometric Coefficient of Variation 30.02
|
1088.7 hr*ng/ml
Geometric Coefficient of Variation 49.45
|
1590.5 hr*ng/ml
Geometric Coefficient of Variation 43.49
|
984.4 hr*ng/ml
Geometric Coefficient of Variation 72.57
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 1)
|
222.8 ng/ml
Geometric Coefficient of Variation 58.13
|
362 ng/ml
Geometric Coefficient of Variation 46.74
|
432.6 ng/ml
Geometric Coefficient of Variation 56.3
|
245.4 ng/ml
Geometric Coefficient of Variation 63.08
|
328.4 ng/ml
Geometric Coefficient of Variation 59.07
|
243.5 ng/ml
Geometric Coefficient of Variation 53.27
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 1)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=8 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 1)
|
1.1 hr
Interval 0.5 to 4.0
|
1.1 hr
Interval 1.0 to 3.8
|
1.1 hr
Interval 1.0 to 4.1
|
2 hr
Interval 1.0 to 2.1
|
4 hr
Interval 0.5 to 4.1
|
2 hr
Interval 0.6 to 2.3
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 15)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase Ib: PK Parameters for MEK162 - AUC0-8hr (Cycle 1; Day 15)
|
1275.8 hr*ng/ml
Geometric Coefficient of Variation 39.04
|
1807.4 hr*ng/ml
Geometric Coefficient of Variation 43.6
|
1927.9 hr*ng/ml
Geometric Coefficient of Variation 42.48
|
1374.2 hr*ng/ml
Geometric Coefficient of Variation 68.21
|
1454.7 hr*ng/ml
Geometric Coefficient of Variation 41.13
|
1268.5 hr*ng/ml
Geometric Coefficient of Variation 70.41
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 15)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase lb: PK Parameters for MEK162 - Cmax (Cycle 1; Day 15)
|
284.1 ng/ml
Geometric Coefficient of Variation 52.79
|
454.5 ng/ml
Geometric Coefficient of Variation 42.42
|
418.9 ng/ml
Geometric Coefficient of Variation 34.62
|
307 ng/ml
Geometric Coefficient of Variation 88.45
|
362.7 ng/ml
Geometric Coefficient of Variation 59.8
|
340.7 ng/ml
Geometric Coefficient of Variation 80.64
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 (Day 15)Population: This analysis group is comprised of the Pharmacokinetic Analysis Set (PAS), which is all patients who have evaluable pharmacokinetic (PK) data. The PAS will be used for summaries (tables and figures) and listings of PK data.
Blood samples were collected from all patients during Cycle 1 (Days 1 and 15) for pharmacokinetic profiling. On Days 8 and 22 of Cycle 1, trough samples were collected. Additionally, pre-dose samples were collected on Day 1 of Cycle 2 through Cycle 6.
Outcome measures
| Measure |
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)
n=6 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)
n=4 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)
n=5 Participants
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase II (Dose Expansion)
Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
|
|---|---|---|---|---|---|---|---|
|
Phase lb: PK Parameters for MEK162 - Tmax (Cycle 1; Day 15)
|
1.5 hr
Interval 0.5 to 8.0
|
2 hr
Interval 1.1 to 8.3
|
1.6 hr
Interval 1.1 to 4.0
|
3 hr
Interval 1.0 to 8.2
|
2.9 hr
Interval 2.0 to 4.1
|
1.9 hr
Interval 0.5 to 2.1
|
—
|
Adverse Events
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)
Serious events: 4 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)
n=6 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)
n=6 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)
n=6 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)
n=6 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)
n=6 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)
n=8 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
|---|---|---|---|---|---|---|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
FATIGUE
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
MALAISE
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
PYREXIA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
NAUSEA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
4/8 • Number of events 4 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Hepatobiliary disorders
ACUTE HEPATIC FAILURE
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Endocrine disorders
HYPOTHYROIDISM
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Infections and infestations
INFECTION
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
Other adverse events
| Measure |
Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)
n=6 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)
n=6 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)
n=6 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)
n=6 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)
n=6 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)
n=8 participants at risk
Phase Ib (Dose Escalation)
Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid.
|
|---|---|---|---|---|---|---|
|
Vascular disorders
HYPERTENSION
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
37.5%
3/8 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR PAIN
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
FATIGUE
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
66.7%
4/6 • Number of events 4 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
62.5%
5/8 • Number of events 5 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
OEDEMA PERIPHERAL
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
66.7%
4/6 • Number of events 4 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
37.5%
3/8 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
ASTHENIA
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
37.5%
3/8 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
PYREXIA
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
MALAISE
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
General disorders
CHILLS
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
66.7%
4/6 • Number of events 4 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
83.3%
5/6 • Number of events 5 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
66.7%
4/6 • Number of events 4 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Investigations
WEIGHT DECREASED
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Investigations
EJECTION FRACTION DECREASED
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Investigations
BLOOD LACTATE DEHYDROGENASE INCREASED
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
ANAEMIA
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
DYSGEUSIA
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
CEREBROVASCULAR DISORDER
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
NEUROPATHY PERIPHERAL
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Nervous system disorders
PRESYNCOPE
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
CHORIORETINOPATHY
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
62.5%
5/8 • Number of events 5 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
RETINAL DETACHMENT
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
VISION BLURRED
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
VISUAL IMPAIRMENT
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
37.5%
3/8 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
CATARACT
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
EYE DISORDER
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
EYELID OEDEMA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
MACULAR OEDEMA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
PERIORBITAL OEDEMA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
RETINAL OEDEMA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Eye disorders
RETINOPATHY
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
DIARRHOEA
|
100.0%
6/6 • Number of events 6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
83.3%
5/6 • Number of events 5 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
100.0%
6/6 • Number of events 6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
100.0%
6/6 • Number of events 6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
100.0%
6/6 • Number of events 6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
100.0%
8/8 • Number of events 8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
NAUSEA
|
100.0%
6/6 • Number of events 6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
66.7%
4/6 • Number of events 4 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
100.0%
6/6 • Number of events 6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
66.7%
4/6 • Number of events 4 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
87.5%
7/8 • Number of events 7 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
VOMITING
|
83.3%
5/6 • Number of events 5 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
83.3%
5/6 • Number of events 5 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
83.3%
5/6 • Number of events 5 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
83.3%
5/6 • Number of events 5 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
87.5%
7/8 • Number of events 7 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
CONSTIPATION
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
4/8 • Number of events 4 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
DRY MOUTH
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
GASTRITIS
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Hepatobiliary disorders
HEPATIC PAIN
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Renal and urinary disorders
CHROMATURIA
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Renal and urinary disorders
RENAL COLIC
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
RASH
|
83.3%
5/6 • Number of events 5 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
DERMATITIS ACNEIFORM
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
50.0%
3/6 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
ALOPECIA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
PAIN OF SKIN
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
HYPERHIDROSIS
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
RASH FOLLICULAR
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Skin and subcutaneous tissue disorders
XERODERMA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
37.5%
3/8 • Number of events 3 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPOALBUMINAEMIA
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
33.3%
2/6 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/8 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
16.7%
1/6 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
12.5%
1/8 • Number of events 1 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
|
Infections and infestations
RASH PUSTULAR
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
0.00%
0/6 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
66.7%
4/6 • Number of events 4 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
25.0%
2/8 • Number of events 2 • Adverse Events (AEs) were collected for approximately 2 years (August, 2013 through May, 2015), which was the duration of the trial.
AE reporting is comprised of the Safety Set (SS), which is all patients who received at least one dose of AEB071 and MEK162, and have at least one valid post-baseline safety assessment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of the sponsor's agreements with its investigators may vary. However, the sponsor does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e. data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER