Trial Outcomes & Findings for RTA 408 Capsules in Patients With Melanoma - REVEAL (NCT NCT02259231)
NCT ID: NCT02259231
Last Updated: 2025-06-04
Results Overview
Best overall response rate (ORR) is defined as the proportion of patients with complete or partial tumor size reduction according to RECIST v1.1 criteria. Stable disease is not a component of ORR. Complete response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial reduction: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The first occurrence of a response is considered an unconfirmed response. A CR or PR which persists to the next tumor burden assessment is then considered a confirmed response. Confirmed plus unconfirmed best overall response are presented. A subject may be counted twice if best unconfirmed response and best confirmed response are different.
COMPLETED
PHASE1/PHASE2
41 participants
From enrollment up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab
2025-06-04
Participant Flow
Participant milestones
| Measure |
Omaveloxolone 5 mg & Ipilimumab
Omaveloxolone (RTA 408) capsules, Dose1 taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
|
Omaveloxolone 10 mg & Ipilimumab
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 5 mg & Nivolumab
Omaveloxolone (RTA 408) capsules, 5 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
|
Omaveloxolone 10 mg & Nivolumab
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 20 mg & Nivolumab
Omaveloxolone (RTA 408) capsules, 20 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 100 mg & Nivolumab
Omaveloxolone (RTA 408) capsules, 100 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 150 mg & Nivolumab
Omaveloxolone (RTA 408) capsules, 150 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
6
|
6
|
6
|
5
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
6
|
6
|
6
|
6
|
5
|
Reasons for withdrawal
| Measure |
Omaveloxolone 5 mg & Ipilimumab
Omaveloxolone (RTA 408) capsules, Dose1 taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
|
Omaveloxolone 10 mg & Ipilimumab
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 5 mg & Nivolumab
Omaveloxolone (RTA 408) capsules, 5 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
|
Omaveloxolone 10 mg & Nivolumab
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 20 mg & Nivolumab
Omaveloxolone (RTA 408) capsules, 20 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 100 mg & Nivolumab
Omaveloxolone (RTA 408) capsules, 100 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 150 mg & Nivolumab
Omaveloxolone (RTA 408) capsules, 150 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Progressive Disease
|
4
|
5
|
4
|
5
|
4
|
5
|
4
|
|
Overall Study
Sponsor termination of study
|
1
|
0
|
0
|
1
|
2
|
1
|
1
|
Baseline Characteristics
RTA 408 Capsules in Patients With Melanoma - REVEAL
Baseline characteristics by cohort
| Measure |
Omaveloxolone 5 mg & Ipilimumab
n=6 Participants
Omaveloxolone (RTA 408) capsules, Dose1 taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
|
Omaveloxolone 10 mg & Ipilimumab
n=6 Participants
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 5 mg & Nivolumab
n=6 Participants
Omaveloxolone (RTA 408) capsules, 5 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
|
Omaveloxolone 10 mg & Nivolumab
n=6 Participants
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 20 mg & Nivolumab
n=6 Participants
Omaveloxolone (RTA 408) capsules, 20 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 100 mg & Nivolumab
n=6 Participants
Omaveloxolone (RTA 408) capsules, 100 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 150 mg & Nivolumab
n=5 Participants
Omaveloxolone (RTA 408) capsules, 150 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.17 years
STANDARD_DEVIATION 18.713 • n=5 Participants
|
53.5 years
STANDARD_DEVIATION 8.24 • n=7 Participants
|
68.33 years
STANDARD_DEVIATION 12.42 • n=5 Participants
|
51.67 years
STANDARD_DEVIATION 11.29 • n=4 Participants
|
60.5 years
STANDARD_DEVIATION 13.882 • n=21 Participants
|
65 years
STANDARD_DEVIATION 7.321 • n=10 Participants
|
65 years
STANDARD_DEVIATION 5.958 • n=115 Participants
|
60.3 years
STANDARD_DEVIATION 12.49 • n=24 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
17 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
4 Participants
n=115 Participants
|
24 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
2 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
39 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
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
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
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
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
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
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
5 Participants
n=115 Participants
|
41 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
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
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
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
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: From enrollment up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with NivolumabPopulation: Evaluable analysis set (EAS) is defined as all enrolled patients having received at least two weeks of study drug before disease progression and excludes patients who discontinued from study for reasons other than an adverse event prior to first tumor restaging.
Best overall response rate (ORR) is defined as the proportion of patients with complete or partial tumor size reduction according to RECIST v1.1 criteria. Stable disease is not a component of ORR. Complete response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial reduction: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. The first occurrence of a response is considered an unconfirmed response. A CR or PR which persists to the next tumor burden assessment is then considered a confirmed response. Confirmed plus unconfirmed best overall response are presented. A subject may be counted twice if best unconfirmed response and best confirmed response are different.
Outcome measures
| Measure |
Omaveloxolone 5 mg & Ipilimumab
n=6 Participants
Omaveloxolone (RTA 408) capsules, Dose1 taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
|
Omaveloxolone 10 mg & Ipilimumab
n=3 Participants
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 5 mg & Nivolumab
n=6 Participants
Omaveloxolone (RTA 408) capsules, 5 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
|
Omaveloxolone 10 mg & Nivolumab
n=4 Participants
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 20 mg & Nivolumab
n=5 Participants
Omaveloxolone (RTA 408) capsules, 20 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 100 mg & Nivolumab
n=5 Participants
Omaveloxolone (RTA 408) capsules, 100 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 150 mg & Nivolumab
n=5 Participants
Omaveloxolone (RTA 408) capsules, 150 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
|---|---|---|---|---|---|---|---|
|
Measure of Efficacy of the Phase 2 Dose of RTA 408 in Combination With Nivolumab Using Overall Response Rate (ORR; Complete Plus Partial Responses) According to RECIST Version 1.1 Criteria
Best Overall Responses
|
6 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Measure of Efficacy of the Phase 2 Dose of RTA 408 in Combination With Nivolumab Using Overall Response Rate (ORR; Complete Plus Partial Responses) According to RECIST Version 1.1 Criteria
Progressive Disease
|
3 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Measure of Efficacy of the Phase 2 Dose of RTA 408 in Combination With Nivolumab Using Overall Response Rate (ORR; Complete Plus Partial Responses) According to RECIST Version 1.1 Criteria
Stable Disease
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Measure of Efficacy of the Phase 2 Dose of RTA 408 in Combination With Nivolumab Using Overall Response Rate (ORR; Complete Plus Partial Responses) According to RECIST Version 1.1 Criteria
Partial Response
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Measure of Efficacy of the Phase 2 Dose of RTA 408 in Combination With Nivolumab Using Overall Response Rate (ORR; Complete Plus Partial Responses) According to RECIST Version 1.1 Criteria
Complete Response
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Omaveloxolone 5 mg & Ipilimumab
Omaveloxolone 10 mg & Ipilimumab
Omaveloxolone 5 mg & Nivolumab
Omaveloxolone 10 mg & Nivolumab
Omaveloxolone 20 mg & Nivolumab
Omaveloxolone 100 mg & Nivolumab
Omaveloxolone 150 mg & Nivolumab
Serious adverse events
| Measure |
Omaveloxolone 5 mg & Ipilimumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, Dose1 taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
|
Omaveloxolone 10 mg & Ipilimumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 5 mg & Nivolumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, 5 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
|
Omaveloxolone 10 mg & Nivolumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 20 mg & Nivolumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, 20 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 100 mg & Nivolumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, 100 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 150 mg & Nivolumab
n=5 participants at risk
Omaveloxolone (RTA 408) capsules, 150 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
|---|---|---|---|---|---|---|---|
|
Infections and infestations
Lung Infection
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Soft tissue infection
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Cerebral thrombosis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Disease progression
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood creatinine phosphokinase increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Troponin increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
Other adverse events
| Measure |
Omaveloxolone 5 mg & Ipilimumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, Dose1 taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
|
Omaveloxolone 10 mg & Ipilimumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 168 weeks, plus ipilimumab (3 mg/kg) administered at weeks 1, 4, 7, and 10.
Ipilimumab (3 mg/kg): Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 5 mg & Nivolumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, 5 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Omaveloxolone Capsules (2.5 mg/capsule): Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
|
Omaveloxolone 10 mg & Nivolumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, 10 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 20 mg & Nivolumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, 20 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (10 mg/capsule): Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 100 mg & Nivolumab
n=6 participants at risk
Omaveloxolone (RTA 408) capsules, 100 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
Omaveloxolone 150 mg & Nivolumab
n=5 participants at risk
Omaveloxolone (RTA 408) capsules, 150 mg taken orally once daily for 169 weeks, plus nivolumab (240 mg) administered every two weeks as clinically indicated.
Nivolumab (240 mg): Sterile solution containing nivolumab to be delivered intravenously at 240 mg
Omaveloxolone Capsules (50 mg/capsule): Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
40.0%
2/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Cardiac disorders
Sinus tachycardia
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Congenital, familial and genetic disorders
Multiple lentigines syndrome
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Ear and labyrinth disorders
Vertigo
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Endocrine disorders
Hypophysitis
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Endocrine disorders
Hypothyroidism
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Eye disorders
Dry eye
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Eye disorders
Eye disorder
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Eye disorders
Eye irritation
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Eye disorders
Mydriasis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Eye disorders
Photophobia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
66.7%
4/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
40.0%
2/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Gastric ulcer
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
66.7%
4/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
66.7%
4/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
66.7%
4/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Oesophageal disorder
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Chills
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Early satiety
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Face oedema
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Fatigue
|
83.3%
5/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
83.3%
5/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
83.3%
5/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
100.0%
6/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
60.0%
3/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Influenza like illness
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Localised oedema
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Malaise
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Nodule
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Non-cardiac chest pain
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Oedema peripheral
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Pain
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
General disorders
Pyrexia
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
40.0%
2/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Immune system disorders
Hypersensitivity
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Gastroenteritis
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Pneumonia
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Skin infection
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Soft tissue infection
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Upper respiratory tract infection
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Alanine aminotransferase increased
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Aspartate aminotransferase increased
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Biopsy site unspecified abnormal
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood alkaline phosphatase increased
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood corticotrophin decreased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood creatinine increased
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood potassium increased
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood testosterone decreased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood triglycerides increased
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Brain natriuretic peptide increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Cardiac murmur
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Electrocardiogram QT prolonged
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Heart rate increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Low density lipoprotein increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Oesophagogastroduodenoscopy
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Platelet count decreased
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Serum ferritin decreased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Troponin increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Very low density lipoprotein increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
40.0%
2/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
Weight increased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
40.0%
2/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
40.0%
2/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
40.0%
2/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign vaginal neoplasm
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Dizziness
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Headache
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Speech disorder developmental
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Psychiatric disorders
Decreased activity
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Renal and urinary disorders
Polyuria
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Renal and urinary disorders
Urinary hesitation
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
40.0%
2/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
40.0%
2/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
60.0%
3/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Orthopnoea
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
4/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
50.0%
3/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
33.3%
2/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Systemic lupus erythematosus rash
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Surgical and medical procedures
Micrographic skin surgery
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Vascular disorders
Hot flush
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Vascular disorders
Hypertension
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
20.0%
1/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Vascular disorders
Jugular vein thrombosis
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
16.7%
1/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/6 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
0.00%
0/5 • Adverse events were reported from time of the first dose of study drug up to the time of disease progression, up to 172 weeks for participants receiving Omaveloxolone in combination with Ipilimumab and 173 weeks for participants receiving Omaveloxolone combination with Nivolumab.
Collection of adverse event information was done based on regular investigator assessment during patients visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER